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Broad Spectrum SPF 30 All skin types Water Resistant

Date post: 02-Apr-2022
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SPF 30 FACE MOISTURIZER- avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion Malin and Goetz Inc Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- SPF 30 Face Moisturizer Active Ingredient Purpose Avobenzone 3% sunscreen Homosalate 10% sunscreen Octinoxate 7.5% sunscreen Octisalate 2.75% sunscreen Oxybenzone 5% sunscreen Uses Helps prevent sunburn If used as directed with other sun proctection measures (see Directions ) decreases the risk of skin cancer and early skin aging caused by the sun Retains SPF up to 80 minutes of activity in the water Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away Stop use and ask a doctor if: Rash or irritation develops and lasts. Warnings For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Directions Apply liberally and evenly to dry skin 15 minutes before sun exposure and as often as needed. Re-apply at least every 2 hours; after 80 minutes of swimming or perspiring; immediately after towel drying. Children under 6 months of age, consult your physician Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regualarly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun from 10am-2pm wear long sleeve shirts, pants, hats and sunglasses Water(Aqua), Butyloctyl Salicylate, Dimethicone, Corn Start Modified, Hexylene Glycol, VP/Eicosene Copolymer, Glcyerin, Cetearyl Alcohol, PEG-12 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Panthenol, Allantoin, Aloe Barbadensis Leaf Juice Powder, Butyrospermum Parkii (shea) Oil, Epilobium Angustifolium Flower/leaf/stem extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sorbitan Stearate, Xanthan Gum, Caprylyl Glycol, Ethylhexylglycerin, Calcium Pantothenate, Sodium Hydroxide, Chlorphenesin, Disodium EDTA, Potassium Sorbate, PEG-40 Stearate, Phenoxyethanol (Malin + Goetz)
Transcript

SPF 30 FACE MOISTURIZER- avobenzone, homosalate, octinoxate, octisalate,oxybenzone lotion Malin and Goetz IncDisclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if theycomply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SPF 30 Face Mois turizerActive Ingredient Purpose

Avobenzone 3% sunscreen

Homosalate 10% sunscreen

Octinoxate 7.5% sunscreen

Octisalate 2.75% sunscreen

Oxybenzone 5% sunscreen

UsesHelps prevent sunburn

If used as directed with other sun proctection measures (see Directions ) decreases the risk of skincancer and early skin aging caused by the sunRetains SPF up to 80 minutes of activity in the water

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center rightaway

Stop use and ask a doctor if: Rash or irritation develops and lasts.

Warnings For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

DirectionsApply liberally and evenly to dry skin 15 minutes before sun exposure and as often as needed.Re-apply at least every 2 hours; after 80 minutes of swimming or perspiring; immediately aftertowel drying.Children under 6 months of age, consult your physicianSun Protection Measures . Spending time in the sun increases your risk of skin cancer and earlyskin aging. To decrease this risk, regualarly use a sunscreen with a broad spectrum SPF of 15 orhigher and other sun protection measures including: Limit time in the sun from 10am-2pmwear long sleeve shirts, pants, hats and sunglasses

Water(Aqua), Butyloctyl Salicylate, Dimethicone, Corn Start Modified, Hexylene Glycol, VP/EicoseneCopolymer, Glcyerin, Cetearyl Alcohol, PEG-12 Dimethicone, Tetrahexyldecyl Ascorbate,Tocopheryl Acetate, Panthenol, Allantoin, Aloe Barbadensis Leaf Juice Powder, Butyrospermum Parkii(shea) Oil, Epilobium Angustifolium Flower/leaf/stem extract, Acrylates/C10-30 Alkyl AcrylateCrosspolymer, Sorbitan Stearate, Xanthan Gum, Caprylyl Glycol, Ethylhexylglycerin, CalciumPantothenate, Sodium Hydroxide, Chlorphenesin, Disodium EDTA, Potassium Sorbate, PEG-40Stearate, Phenoxyethanol

(Malin + Goetz)

SPF 30 Face Moisturizer

Broad Spectrum SPF 30 All skin types

Water Resistant

1.7 fl. oz. 50 ml

SPF 30 FACE MOISTURIZER avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion

Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:536 34-255

Route of Adminis tration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX) AVOBENZONE 3 g in 10 0 mL

HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S) HOMOSALATE 10 g in 10 0 mL

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 10 0 mL

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W) OCTISALATE 2.75 in 10 0 mL

O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y) OXYBENZONE 5 in 10 0 mL

Inactive IngredientsIngredient Name Strength

WATER (UNII: 0 59 QF0 KO0 R)

BUTYLO CTYL SALICYLATE (UNII: 2EH13UN8 D3)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

MO DIFIED CO RN STARCH ( 1-O CTENYL SUCCINIC ANHYDRIDE) (UNII: 46 1P5CJN6 T)

HEXYLENE GLYCO L (UNII: KEH0 A3F75J)

VINYLPYRRO LIDO NE/EICO SENE CO PO LYMER (UNII: 0 35MV9 S1C3)

GLYCERIN (UNII: PDC6 A3C0 OX)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

PEG-12 DIMETHICO NE (UNII: ZEL54N6 W9 5)

TETRAHEXYLDECYL ASCO RBATE (UNII: 9 LBV3F0 7AZ)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

PANTHENO L (UNII: WV9 CM0 O6 7Z)

ALLANTO IN (UNII: 344S277G0 Z)

ALO E FERO X LEAF (UNII: 0 D145J8 EME)

SHEANUT O IL (UNII: O8 8 E19 6 QRF)

EPILO BIUM ANGUSTIFO LIUM FLO WERING TO P (UNII: 0 8 H0 9 4218 D)

CARBO MER CO PO LYMER TYPE A ( ALLYL PENTAERYTHRITO L CRO SSLINKED) (UNII: 71DD5V9 9 5L)

SO RBITAN MO NO STEARATE (UNII: NVZ4I0 H58 X)

XANTHAN GUM (UNII: TTV12P4NEE)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

CALCIUM PANTO THENATE (UNII: 56 8 ET8 0 C3D)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

PEG-4 0 STEARATE (UNII: ECU18 C6 6 Q7)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:536 34-255-0 2 1 in 1 CARTON 12/0 5/20 17

1 NDC:536 34-255-0 1 50 mL in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

OTC mo no graph fina l part352 12/0 5/20 17

Labeler - Malin and Goetz Inc (138615930)

Malin and Goetz Inc

EstablishmentName Addre ss ID/FEI Bus ine ss Ope rations

Milbar Labo ra to ries,Inc . 19 5556 79 0 manufacture(536 34-255)

Revised: 1/2021


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