Label: EQUATE ZIINC SUNSCREEN ULTRA BROAD SPECTRUM- octinoxate, titanium dioxide, zinc oxide cream
- NDC Code(s): 49035-564-42, 49035-564-43
- Packager: Walmart 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 19, 2021
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- 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 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-sleeve shirts, pants, hats, and sunglasses
- Other information
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Inactiveingredients
water, C12-15 alkyl benzoate, cetyl dimethicone, cetyl PEG/PPG-10/1 dimethicone, caprylic/capric triglyceride, ethylhexyl palmitate, tridecyl salicylate, polyethylene, tetradecane, hydrogenated castor oil, hydrogenated polydecene, aloe barbadensis leaf juice, butylene glycol, ethylhexyl stearate, cyclopentasiloxane, cyclohexsiloxane, caprylyl glycol, phenoxyethanol, hydroxyethylcellulose, tetrahexyldecyl ascorbate, triethoxycaprylylsilane, hexylene glycol, dimethicone, tocopheryl acetate, camellia sinensis (green tea) leaf extract, sodium chloride
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EQUATE ZIINC SUNSCREEN ULTRA BROAD SPECTRUM
octinoxate, titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-564 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 50 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 91 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ETHYLHEXYL PALMITATE (UNII: 2865993309) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) TETRADECANE (UNII: 03LY784Y58) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) HEXYLENE GLYCOL (UNII: KEH0A3F75J) DIMETHICONE (UNII: 92RU3N3Y1O) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SODIUM CHLORIDE (UNII: 451W47IQ8X) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CYCLOMETHICONE 6 (UNII: XHK3U310BA) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-564-43 1 in 1 PACKAGE 02/20/2019 1 NDC:49035-564-42 29.6 mL in 1 JAR; 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 02/20/2019 Labeler - Walmart Stores Inc. (051957769)
