Label: EQUATE SPF 50 ULTRA ZINC SUNSCREEN- octocrylene, zinc oxide lotion
- NDC Code(s): 49035-753-42
- Packager: Wal-Mart Stores 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 October 28, 2022
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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Directions
- apply liberally 15 minutes before sun exposure.
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- children under 6 months of age: Ask a doctor
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with 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
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Inactive ingredients
water, ethylhexyl stearate, diisopropyl adipate, cetyl dimethicone, polyglyceryl-4 isostearate, cetyl PEG/PPG-10/1 dimethicone, hexyl laurate, phenoxyethanol, beeswax, isohexadecane, hydrogenated castor oil, fragrance, silica, triethoxycaprylylsilane, dimethicone, tocopherol (Vitamin E), tetrasodium EDTA, aloe barbadensis leaf juice, sodium chloride, sodium ascorbyl phosphate.
- Label
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INGREDIENTS AND APPEARANCE
EQUATE SPF 50 ULTRA ZINC SUNSCREEN
octocrylene, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-753 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 50.2125 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) EDETATE SODIUM (UNII: MP1J8420LU) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) HEXYL LAURATE (UNII: 4CG9F9W01Q) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) ALOE VERA LEAF (UNII: ZY81Z83H0X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) YELLOW WAX (UNII: 2ZA36H0S2V) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) ISOHEXADECANE (UNII: 918X1OUF1E) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) DIMETHICONE (UNII: 92RU3N3Y1O) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-753-42 29.6 mL in 1 JAR; Type 0: Not a Combination Product 08/12/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/12/2019 Labeler - Wal-Mart Stores Inc (051957769)
