Label: EQUATE SPF 50 ULTRA SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 49035-759-12, 49035-759-14
- 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, tridecyl salicylate, sorbitol, polyethyloxazoline, stearic acid, triethanolamine, aluminum starch octenylsuccinate, carbomer, polyglyceryl-3 distearate, dimethicone, sorbitan isostearate, fragrance, benzyl alcohol, caprylyl glycol, phenoxyethanol, ethylhexylglycerin, tocopherol (Vitamin E), disodium EDTA.
- Label
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INGREDIENTS AND APPEARANCE
EQUATE SPF 50 ULTRA SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-759 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 150 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 70 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) PHENOXYETHANOL (UNII: HIE492ZZ3T) STEARIC ACID (UNII: 4ELV7Z65AP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) DIMETHICONE (UNII: 92RU3N3Y1O) BENZYL ALCOHOL (UNII: LKG8494WBH) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) TROLAMINE (UNII: 9O3K93S3TK) EDETATE DISODIUM (UNII: 7FLD91C86K) POLYETHYLOXAZOLINE (500000 MW) (UNII: S5DPG6K67I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-759-12 236 mL in 1 TUBE; Type 0: Not a Combination Product 06/04/2019 2 NDC:49035-759-14 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/04/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/04/2019 Labeler - Wal-Mart Stores Inc (051957769)
