Label: PREMIUM SUNSCREEN SPF-30- zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 71585-105-21 - Packager: SALT AND STONE
- 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 July 28, 2019
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENTS
- PURPOSE
- USE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DIRECTIONS
For use on children less than 6 months of age, consult a health care practitioner. Apply liberally/generously (and evenly) 15 minutes before sun exposure. Reapply at least every 2 hours. Reapply after 80 minutes of swimming or sweating. Reapply immediately after towel drying. 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 10am - 2pm. wear long-sleeved shirts, pants, hats and sunglasses.
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INACTIVE INGREDIENTS
*Aloe Barbadensis Juice, *Cera Alba (Beeswax), Cetearyl Alcohol, Citric Acid, *Cocos Nucifera (Coconut) Oil, Glyceryl Stearate, *Helianthus Annuus (Sunflower) Seed Oil, Hydroxyethylcellulose, Phenoxyethanol, *Simmondsia Chinesnsis (Jojoba) Oil, Sodium Citrate, Sodium Stearoyl Lactylate, Stearic Acid, *Theobroma Cacao (Cocoa) Butter, *Tocopherol (Vitamin E), *Vanilla, *Vitellaria Paradox (Shea) Butter, Xanthan Gum
*Certified Organic
- OTHER INFORMATION
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INGREDIENTS AND APPEARANCE
PREMIUM SUNSCREEN SPF-30
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71585-105 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 20 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) YELLOW WAX (UNII: 2ZA36H0S2V) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) COCONUT OIL (UNII: Q9L0O73W7L) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SUNFLOWER OIL (UNII: 3W1JG795YI) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) PHENOXYETHANOL (UNII: HIE492ZZ3T) JOJOBA OIL (UNII: 724GKU717M) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) STEARIC ACID (UNII: 4ELV7Z65AP) COCOA BUTTER (UNII: 512OYT1CRR) TOCOPHEROL (UNII: R0ZB2556P8) VANILLA (UNII: Q74T35078H) SHEA BUTTER (UNII: K49155WL9Y) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71585-105-21 88 mL in 1 TUBE; Type 0: Not a Combination Product 08/29/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/29/2017 Labeler - SALT AND STONE (080683697)
