Label: EQUATE ZINC OXIDE SUNSCREEN SPF 50- zinc oxide cream
- NDC Code(s): 49035-961-00
- 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 March 25, 2019
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- Drug Facts
- Active ingredients
- Uses
- Warnings
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Directions
apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use water resistant sunscreen if swimming or sweating
- 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 sking 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, caprylic/capric triglyceride, styrene/acrylates copolymer, dimethicone, cety PEG/PPG-10/1 dimethicone, cetyl dimethicone, glycerin, octyldodecyl citrate crosspolymer, phenyl trimethicone, phenethyl alcohol, ethylhexylglycerin, coco-caprylate/caprate, isostearic acid, sodium chloride, colloidal oatmeal, silica, polyglyceryl-3 polyricinoleate, glycery behenate, cyclopentasiloxane, acrylates/dimethicone copolymer, behenyl dimethicone/bis divinyldimethicone crosspolymer, triethoxycaprylylsilane, crysanthemum parthenium extract.
- Package Labeling:
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INGREDIENTS AND APPEARANCE
EQUATE ZINC OXIDE SUNSCREEN SPF 50
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-961 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 216 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) ISOSTEARIC ACID (UNII: X33R8U0062) SODIUM CHLORIDE (UNII: 451W47IQ8X) OATMEAL (UNII: 8PI54V663Y) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERYL DIBEHENATE (UNII: R8WTH25YS2) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) TANACETUM PARTHENIUM (UNII: 6GE7Z0761K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-961-00 235 mL in 1 TUBE; Type 0: Not a Combination Product 08/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/01/2019 Labeler - Wal-Mart Stores Inc (051957769)