Active ingredients

Titanium Dioxide 3%

Zinc Oxide 4%

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

on damaged or broken skin.

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply liberally 15 minutes before sun exposure
reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- 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 a broad spectrum SPF of 15 or higher and other sun protection measures including:
- limit time in sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
Children under 6 months: Ask a doctor

Inactive Ingredients

Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aluminum Hydroxide, Argania spinosa (Argan) Kernel Oil, C12-15 Alkyl Benzoate, Ceteareth-20, Cetyl Alcohol, Dibutyl Adipate, Dimethicone, Glycerin, Hexyl Laurate, Iron Oxides, Lecithin, Magnesium Aluminum Silicate, Malus Domestica Fruit Cell Culture Extract, Methylisothiazolinone, PEG-12 Dimethicone, Phenoxyethanol, Polyglyceryl-3 Distearate, Stearic Acid, Stearyl Alcohol, Triethoxycaprylylsilane, Water (Aqua), Xanthan Gum

Other information

protect this product from excesive heat and direct sun.

Eternal Spirit Beauty Sunscreen Lotion Broad Spectrum SPF 30 Mineral Sunscreen

Principle Display Label

ETERNAL SPIRIT BEAUTY BROAD SPECTRUM SPF 30
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58443-0413
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	31.2 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	41.6 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
DIMETHICONE (UNII: 92RU3N3Y1O)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
XANTHAN GUM (UNII: TTV12P4NEE)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ARGAN OIL (UNII: 4V59G5UW9X)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIBUTYL ADIPATE (UNII: F4K100DXP3)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
APPLE (UNII: B423VGH5S9)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Product Characteristics
Color	brown (Tan)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58443-0413-3	59 mL in 1 TUBE; Type 0: Not a Combination Product	02/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	02/01/2016

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	label(58443-0413) , pack(58443-0413) , manufacture(58443-0413) , analysis(58443-0413)