Label: SELF REFLECT PROBIOTIC SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF 32- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 62742-4181-1, 62742-4181-2 - Packager: Allure Labs 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 December 12, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS AND PRECAUTIONS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions:
- Apply generously 15 minutes before sun exposer.
- Use a water resistant sunscreen if swimming or sweating.
- Reapply at least every 2 hours.
- Sun protection measures: Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10am - 2pm.
- Wear long sleeved shirts, pants, hats and sunglasses.
- Children under 6 months: Ask a doctor.
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INACTIVE INGREDIENT
Inactive Ingredients: Water (Aqua), Caprylyc/Capric Triglyceride, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Pyrus Malus (Apple) Fruit Extract, Coco-Glucoside, Lactobacillus Ferment, Rubus Idaeus (Red Rasberry) Seed Oil, Cocos Nucifera (Coconut) Liquid Endosperm, Curcuma Longa (Turmeric) Rhizomes Oil, Butyrospermum Parkii Nut Extract, Hydrolyzed Jojoba Esters, Tocopherol, Dipotassium Glycyrrhizate, Vanilla Planifolia Fruit Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Butylene Glycol, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Coco-Caprylate/Caprate, Caprylyl/Capryl Glucoside, Sclerotium Gum, Cetearyl Glucoside, Ethylhexylglycerin, Xanthan Gum, Octyldodecanol, Tapioca Starch, Citric Acid, Sorbitan Oleate, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate, May contains +/- Iron Oxides (Cl77491, Cl77492)
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SELF REFLECT PROBIOTIC SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF 32
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4181 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 224 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) COCONUT ALKANES (UNII: 1E5KJY107T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) APPLE (UNII: B423VGH5S9) COCO GLUCOSIDE (UNII: ICS790225B) LACTOBACILLUS REUTERI (UNII: 9913I24QEE) RASPBERRY SEED OIL (UNII: 9S8867952A) COCONUT WATER (UNII: 267F5Y81NT) TURMERIC OIL (UNII: 6KGS8SP16U) SHEANUT (UNII: 84H6HBP32L) HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W) TOCOPHEROL (UNII: R0ZB2556P8) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) VANILLA (UNII: Q74T35078H) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ISOSTEARIC ACID (UNII: X33R8U0062) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0) BETASIZOFIRAN (UNII: 2X51AD1X3T) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) XANTHAN GUM (UNII: TTV12P4NEE) OCTYLDODECANOL (UNII: 461N1O614Y) STARCH, TAPIOCA (UNII: 24SC3U704I) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4181-2 1 in 1 CARTON 12/12/2019 1 NDC:62742-4181-1 50 g in 1 TUBE; 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 12/12/2019 Labeler - Allure Labs Inc (926831603)