DESERT ESSENCE MINERAL SUNSCREEN SPF 35- zinc oxide cream

Desert Essence Mineral Sunscreen SPF 35 by

Drug Labeling and Warnings

Desert Essence Mineral Sunscreen SPF 35 by is a Otc medication manufactured, distributed, or labeled by Autumn Harp, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 components

INGREDIENTS AND APPEARANCE

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

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)