Label: YES TO TOMATOES FRAGRANCE-FREE CLARIFYING MINERAL BROAD SPECTRUM SPF-30- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69840-028-19 - Packager: Yes To, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 January 26, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
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Uses
- helps prevent sunburn.
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- Warnings
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Directions
- apply generously and evenly 15 minutes before sun exposure.
- children under 6 months of age: Ask a doctor.
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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.
- reapply at least every two hours
- use a water resistant sunscreen if swimming or sweating.
- Other Information
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Inactive Ingredients
Water (Aqua), Cocos Nucifera (Coconut) Oil, Diisooctyl Succinate, Tetradecane, Cetearyl Alcohol, Sodium Stearoyl Glutamate, Butyrospermum Parkii (Shea) Butter, Solanum Lycopersicum (Tomato) Fruit Extract, Hamamelis Virginiana (Witch Hazel) Extract, Calcium Sodium Borosilicate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Coco-Glucoside, Diheptyl Succinate, Capryloyl Glycerin/Sebacic Acid Copolymer, Squalane, Bisabolol, Tocopherol, Glycerin, Sodium Gluconate, Xanthan Gum, Citric Acid, Alcohol, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate, Caprylyl Glycol, Caprylhydroxamic Acid.
- Questions?
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Label
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INGREDIENTS AND APPEARANCE
YES TO TOMATOES FRAGRANCE-FREE CLARIFYING MINERAL BROAD SPECTRUM SPF-30
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69840-028 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 157 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Sodium Gluconate (UNII: R6Q3791S76) Sodium Benzoate (UNII: OJ245FE5EU) Potassium Sorbate (UNII: 1VPU26JZZ4) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Alcohol (UNII: 3K9958V90M) Xanthan Gum (UNII: TTV12P4NEE) HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY) TOMATO (UNII: Z4KHF2C175) Phenoxyethanol (UNII: HIE492ZZ3T) Diheptyl Succinate (UNII: 057N7SS26Y) Sodium Stearoyl Glutamate (UNII: 65A9F4P024) Caprylhydroxamic Acid (UNII: UPY805K99W) Caprylyl Glycol (UNII: 00YIU5438U) Glycerin (UNII: PDC6A3C0OX) COCONUT OIL (UNII: Q9L0O73W7L) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) Tetradecane (UNII: 03LY784Y58) Squalane (UNII: GW89575KF9) SHEA BUTTER (UNII: K49155WL9Y) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) Tocopherol (UNII: R0ZB2556P8) TEA TREE OIL (UNII: VIF565UC2G) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) COCO GLUCOSIDE (UNII: ICS790225B) Arachidyl Alcohol (UNII: 1QR1QRA9BU) DOCOSANOL (UNII: 9G1OE216XY) Arachidyl Glucoside (UNII: 6JVW35JOOJ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69840-028-19 50 mL in 1 TUBE; Type 0: Not a Combination Product 02/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 02/01/2022 Labeler - Yes To, Inc. (788689680)
