Label: MINERAL SUNSCREEN SPF 30- zinc oxide spray
- NDC Code(s): 75936-510-01
- Packager: Supergoop, LLC
- 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 October 11, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
Warnings
- For external use only
- Flammable: Contents under pressure. Do not punture or incinerate. Do not store at temperatures above 120 F. Do not use in the precesne of a flame or spark, or while smoking
- Do not use on damaged or broken skin
- When using this product keep out of eyes
- Rinse with water to remove
- Keep out of reach of children
- If swallowed, get medical help or contact a Poison Control Center right away
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DOSAGE & ADMINISTRATION
Directions
SHAKE WELL to activate. If the mist is clear, keep shaking.
- Apply liberally 15 minutes before sun exposure
- Reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours whem exposed to sunlight
- Children un 6 months: 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 epsecially from 10 a.m. - 2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
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INACTIVE INGREDIENT
Aloe Barbadensis Leaf Juice, Bentonite, Butyloctyl Salicylate, Calendula Officinalis Flower Extract, Caprylhydroxamic Acid, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Coco Glucoside, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Heptyl Undecylenate, Jojoba Esters, Melissa Officinalis Leaf Extract, Methyl Dihydroabietate, Nasturtium Officinale Flower/Leaf Extract, Spiraea Ulmaria Flower Extract, Water
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MINERAL SUNSCREEN SPF 30
zinc oxide sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-510 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 12 g in 100 mL Inactive Ingredients Ingredient Name Strength FILIPENDULA ULMARIA ROOT (UNII: 997724QNDS) HEPTYL UNDECYLENATE (UNII: W77QUB6GXO) HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G) FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) BENTONITE (UNII: A3N5ZCN45C) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CAPRYLYL GLYCOL (UNII: 00YIU5438U) GLYCERIN (UNII: PDC6A3C0OX) SAFFLOWER OIL (UNII: 65UEH262IS) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHAMOMILE (UNII: FGL3685T2X) COCO GLUCOSIDE (UNII: ICS790225B) SUNFLOWER OIL (UNII: 3W1JG795YI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-510-01 177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/15/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/15/2017 Labeler - Supergoop, LLC (117061743)