Label: SPF 30 FACE MOISTURIZER- avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 53634-255-01, 53634-255-02 - Packager: Malin and Goetz Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 26, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
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
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INACTIVE INGREDIENT
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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SPF 30 FACE MOISTURIZER
avobenzone, homosalate, octinoxate, octisalate, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53634-255 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.75 in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) DIMETHICONE (UNII: 92RU3N3Y1O) MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T) HEXYLENE GLYCOL (UNII: KEH0A3F75J) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) GLYCERIN (UNII: PDC6A3C0OX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PEG-12 DIMETHICONE (UNII: ZEL54N6W95) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PANTHENOL (UNII: WV9CM0O67Z) ALLANTOIN (UNII: 344S277G0Z) ALOE FEROX LEAF (UNII: 0D145J8EME) SHEANUT OIL (UNII: O88E196QRF) EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) XANTHAN GUM (UNII: TTV12P4NEE) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CALCIUM PANTOTHENATE (UNII: 568ET80C3D) SODIUM HYDROXIDE (UNII: 55X04QC32I) CHLORPHENESIN (UNII: I670DAL4SZ) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PEG-40 STEARATE (UNII: ECU18C66Q7) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53634-255-02 1 in 1 CARTON 12/05/2017 1 NDC:53634-255-01 50 mL in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/05/2017 Labeler - Malin and Goetz Inc (138615930) Establishment Name Address ID/FEI Business Operations Milbar Laboratories,Inc. 195556790 manufacture(53634-255)