Label: DESERT ESSENCE MINERAL SUNSCREEN SPF 35- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51514-0236-1 - Packager: Autumn Harp, 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 July 15, 2013
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children
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Directions
- apply liberally 15 minutes before sun sxposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
- 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 Broad Spectrum SPF 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
- children under 6 months: ask a doctor
- Other information
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Inactive ingredients
Ethyl Palmate, Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunflower) Seed Oil, Sorbitan Olivate, Butyrospermum Parkii (Shea Butter), Beeswax (Cera Alba), Anthemis Nobilis Flower Oil (Chamomile), Punica Granatum Extract (Pomegranate), Punica Granatum Fruit Juice (Pomegranate), Tocopherol (Vitamin E), Glycerin (Palm), Gluconolactone, Sodium Benzoate, Maltodextrin, Silica.
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
DESERT ESSENCE MINERAL SUNSCREEN SPF 35
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51514-0236 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (zinc oxide - UNII:SOI2LOH54Z) ZINC OXIDE 15 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITAN OLIVATE (UNII: MDL271E3GR) SHEA BUTTER (UNII: K49155WL9Y) GLUCONOLACTONE (UNII: WQ29KQ9POT) GLYCERIN (UNII: PDC6A3C0OX) SODIUM BENZOATE (UNII: OJ245FE5EU) TOCOPHEROL (UNII: R0ZB2556P8) ALOE (UNII: V5VD430YW9) CALCIUM GLUCONATE (UNII: SQE6VB453K) POMEGRANATE JUICE (UNII: 99S671U9KB) MALTODEXTRIN (UNII: 7CVR7L4A2D) SOYBEAN OIL (UNII: 241ATL177A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) YELLOW WAX (UNII: 2ZA36H0S2V) POMEGRANATE (UNII: 56687D1Z4D) SUNFLOWER OIL (UNII: 3W1JG795YI) CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9) ETHYL PALMITATE (UNII: IRD3M534ZM) ETHYL OLEATE (UNII: Z2Z439864Y) ETHYL LINOLEATE (UNII: MJ2YTT4J8M) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51514-0236-1 88.7 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 07/15/2013 Labeler - Autumn Harp, Inc. (064187883) Establishment Name Address ID/FEI Business Operations Autumn Harp, Inc. 064187883 manufacture(51514-0236)
