DESERT ESSENCE MINERAL SUNSCREEN SPF 35- zinc oxide cream 
Autumn Harp, Inc.

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.

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Desert Essence Mineral Sunscreen SPF 35

Active Ingredient

Zinc Oxide (15%)

´╗┐Purpose

Sunscreen

Uses

Warnings

For external use only.

´╗┐Do not use

Do not use on damaged or broken skin.

When using this product

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

Stop use and ask a doctor if rash occurs.

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Other information

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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DESERT ESSENCE MINERAL SUNSCREEN SPF 35 
zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51514-0236
Route of Administration TOPICAL DEA Schedule     
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)

Revised: 7/2013
Document Id: fadc97b3-9d98-49ca-8151-4d4a1784843a
Set id: 39580856-ebee-4b20-a582-ddeefe5114da
Version: 1
Effective Time: 20130715
 
Autumn Harp, Inc.