Label: BEAUTY HYDRATING- homosalate, zinc oxide lotion
- NDC Code(s): 36800-513-30
- Packager: Topco
- 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 December 16, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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 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 skin aging. To decrease this risk, regularly use a sunscreen with a Broad spectrum SPF value of 15 or highter and other sun protection measures including:
- limit the time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses
- children under 6 months of age: ask a doctor
- Other information
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Inactive ingredients
water, glycerin, isohexadecane, sodium acrylate/sodium acryloyldimethyl taurate copolymer, polysorbate 80, laureth-7, cyclopentasiloxane, cyclohexasiloxane, tocopheryl acetate, Aloe barbadensis leaf extract, steareth-21, stearyl alcohol, caprylyl glycol, behenyl alcohol, phenoxyethanol, cetyl alcohol, fragrance, hydroxyacetophenone, disodium EDTA, steareth-2, oleth-3 phosphate
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SPL UNCLASSIFIED SECTION
DISTRIBUTED BY TOPCO ASSOCIATES, LLC
ELK GROOVE VILLAGE, KL 60007
TOPCO CIJA0321 QUESTIONS? 1-888-423-0139
topcare@topco.com www.topcarebrand.com
Visit here for more information: http://topbrnds.com/48zz82
QUALITY GUARANTEED
This product is not manufactured or distributed by Procter & Gamble, distributor of Olay Complete UC365 Daily Moisturizer with Sunscreen Broad Spectrum SPF 15 Normal.
**Oxybenzone & Octinoxate Free
May stain or damage some fabrics or surfaces
- principal display panel
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INGREDIENTS AND APPEARANCE
BEAUTY HYDRATING
homosalate, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-513 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 61.2 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 30.6 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX) POLYSORBATE 80 (UNII: 6OZP39ZG8H) LAURETH-7 (UNII: Z95S6G8201) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CYCLOMETHICONE 6 (UNII: XHK3U310BA) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) STEARETH-21 (UNII: 53J3F32P58) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) CAPRYLYL GLYCOL (UNII: 00YIU5438U) DOCOSANOL (UNII: 9G1OE216XY) PHENOXYETHANOL (UNII: HIE492ZZ3T) CETYL ALCOHOL (UNII: 936JST6JCN) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) STEARETH-2 (UNII: V56DFE46J5) OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-513-30 1 in 1 PACKAGE 06/02/2020 1 177 mL in 1 BOTTLE, PLASTIC; 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 06/02/2020 Labeler - Topco (006935977) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(36800-513)
