Label: ESSENTIAL DAILY SUNSCREEN- zinc oxide lotion
- NDC Code(s): 82465-101-11, 82465-101-12, 82465-101-13, 82465-101-14
- Packager: ANTEDOTUM INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 April 1, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DIRECTIONS
- APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
- CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR.
- REAPPLY AT LEAST EVERY 2 HOURS.
- USE A WATER-RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
- SUN PROTECTION MEASURES: SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY AGING. TO DECREASE THE RISK, REGULARLY USE A BROAD SPECTRUM SPF VALUE OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:
- LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 A.M. - 2 P.M.
- WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.
- OTHER INFORMATION
-
INACTIVE INGREDIENTS
WATER, BUTYLENE GLYCOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIMETHICONE, CETEARYL ALCOHOL, CETEARYL OLIVATE, POLYGLYCERYL-3 DIISOSTEARATE, SORBITAN OLIVATE, TOCOPHEROL, POPULUS TREMULOIDES (ASPEN) BARK EXTRACT, TETRAHEXYLDECYL ASCORBATE, CITRUS AURANTIUM AMARA (BITTER ORANGE)FLOWER OIL, HYDROLYZED PEA PROTEIN, GLYCERIN, GLUCOSE, CETEARYL GLUCOSIDE, TRIETHOXYCAPRYLYLSILANE, SODIUM CHLORIDE, SODIUM SUCCINATE, XANTHAN GUM, ETHYLHEXYLGLYCERIN, PHENOXYETHANOL, IRON OXIDES.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ESSENTIAL DAILY SUNSCREEN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82465-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 10 g in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POPULUS TREMULOIDES BARK (UNII: 5543O0CEID) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) WATER (UNII: 059QF0KO0R) CETEARYL OLIVATE (UNII: 58B69Q84JO) CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) FERRIC OXIDE RED (UNII: 1K09F3G675) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM SUCCINATE HEXAHYDRATE (UNII: U16QOD6C4E) DIMETHICONE (UNII: 92RU3N3Y1O) SORBITAN OLIVATE (UNII: MDL271E3GR) TOCOPHEROL (UNII: R0ZB2556P8) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) GLYCERIN (UNII: PDC6A3C0OX) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEA PROTEIN (UNII: 7Q50F46595) ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82465-101-12 1 in 1 BOX 04/01/2022 1 NDC:82465-101-11 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:82465-101-14 1 in 1 BOX 04/01/2022 2 NDC:82465-101-13 10 mL 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 not final part352 04/01/2022 Labeler - ANTEDOTUM INC. (117877223)
