Your browser does not support JavaScript! DESERT ESSENCE MINERAL SUNSCREEN SPF 35 (ZINC OXIDE) CREAM [AUTUMN HARP, INC.]
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DESERT ESSENCE MINERAL SUNSCREEN SPF 35 (zinc oxide) cream
[Autumn Harp, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

Active Ingredient

Zinc Oxide (15%)

Purpose

Sunscreen

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

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

  • 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

  • protect this product container from excessive heat and direct sun

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

image componentsLabel

DESERT ESSENCE MINERAL SUNSCREEN SPF 35 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51514-0236
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (zinc oxide) ZINC OXIDE15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITAN OLIVATE 
SHEA BUTTER 
GLUCONOLACTONE 
GLYCERIN 
SODIUM BENZOATE 
TOCOPHEROL 
ALOE 
CALCIUM GLUCONATE 
POMEGRANATE JUICE 
MALTODEXTRIN 
SOYBEAN OIL 
SILICON DIOXIDE 
YELLOW WAX 
POMEGRANATE 
SUNFLOWER OIL 
CHAMOMILE FLOWER OIL 
ETHYL PALMITATE 
ETHYL OLEATE 
ETHYL LINOLEATE 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51514-0236-188.7 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/15/2013
Labeler - Autumn Harp, Inc. (064187883)
Establishment
NameAddressID/FEIBusiness Operations
Autumn Harp, Inc.064187883manufacture(51514-0236)

Revised: 7/2013
 
Autumn Harp, Inc.

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