NATURAL SPF 28- zinc oxide 11.6%, titanium dioxide 0.67% cream

Natural SPF 28 by

Drug Labeling and Warnings

Natural SPF 28 by is a Otc medication manufactured, distributed, or labeled by CoValence, Inc., CoValence, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s):

11.6% Zinc Oxide, 0.67% Titanium Dioxide

Purpose:

Sunscreen

Warnings: (Keep Out Of Reach Of Children)

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

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 a rash occurs.

Directions:

• Apply liberally 15 minutes before sun exposure.
• 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 a broad spectrum SPF of 15 or higher and other sun protection measures including:  Limit time in the 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:

Alcohol, Allantoin, Aloe Barbadensis Leaf Juice Powder, Alumina, Aqua (Water), Caprylic/Capric Triglyceride, Ceteryl Alcohol, Cetearyl Glucoside, Citric Acid, Coco-Caprylate/Caprate, Dicaprylyl Ether, Fructooligosaccharides (D-Beta), Gluconolactone, Glycerin, Glycine Soja (Soybean) Oil, Glyceryl Isostearate, Hamamelis Virginiana (Witch Hazel) Water, Isononyl Isononanoate, Magnesium Aluminum Silicate, Polyhydroxystearic Acid, Polyglyceryl-6 Polyricinoleate, Polysorbate 60, Potassium Sorbate, Simethicone, Sodium Benzoate, Squalane, Tocopheryl Acetate (D-alpha), Trisodium Ethylenediamine, Xanthan Gum

Other Information:

Protect this product from excessive heat and direct sun.

PDP

INGREDIENTS AND APPEARANCE

NATURAL SPF 28 
zinc oxide 11.6%, titanium dioxide 0.67% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66915-604
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	.116 g  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	.0067 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	1 g  in 1 g
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)	1 g  in 1 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)	1 g  in 1 g
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)	1 g  in 1 g
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)	1 g  in 1 g
POLYSORBATE 60 (UNII: CAL22UVI4M)	1 g  in 1 g
GLYCERIN (UNII: PDC6A3C0OX)	1 g  in 1 g
SQUALANE (UNII: GW89575KF9)	1 g  in 1 g
POLYGLYCERYL-6 DIOLEATE (UNII: 062SZD3F3X)	1 g  in 1 g
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)	1 g  in 1 g
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)	1 g  in 1 g
XANTHAN GUM (UNII: TTV12P4NEE)	1 g  in 1 g
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)	1 g  in 1 g
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)	1 g  in 1 g
ALUMINUM OXIDE (UNII: LMI26O6933)	1 g  in 1 g
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)	1 g  in 1 g
SOYBEAN OIL (UNII: 241ATL177A)	1 g  in 1 g
ALOE VERA LEAF (UNII: ZY81Z83H0X)	1 g  in 1 g
DIMETHICONE (UNII: 92RU3N3Y1O)	1 g  in 1 g
ALLANTOIN (UNII: 344S277G0Z)	1 g  in 1 g
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)	1 g  in 1 g
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)	1 g  in 1 g
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	1 g  in 1 g
POPULUS TREMULOIDES BARK (UNII: 5543O0CEID)	1 g  in 1 g
DICAPRYLYL ETHER (UNII: 77JZM5516Z)	1 g  in 1 g
1,2-HEXANEDIOL (UNII: TR046Y3K1G)	1 g  in 1 g
CAPRYLYL GLYCOL (UNII: 00YIU5438U)	1 g  in 1 g
GLUCONOLACTONE (UNII: WQ29KQ9POT)	1 g  in 1 g
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)	1 g  in 1 g
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)	1 g  in 1 g
TROPOLONE (UNII: 7L6DL16P1T)	1 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66915-604-02	200000 g in 1 DRUM
2	NDC: 66915-604-24	1 in 1 PACKAGE
2	NDC: 66915-604-07	100 g in 1 BOTTLE
3	NDC: 66915-604-22	1 in 1 PACKAGE
3	NDC: 66915-604-08	70 g in 1 TUBE
4	NDC: 66915-604-25	1 in 1 PACKAGE
4	NDC: 66915-604-12	120 g in 1 TUBE
5	NDC: 66915-604-14	30 g in 1 BOTTLE
6	NDC: 66915-604-16	65 g in 1 JAR
7	NDC: 66915-604-17	135 g in 1 JAR
8	NDC: 66915-604-23	1 in 1 PACKAGE
8	NDC: 66915-604-20	70 g in 1 TUBE
9	NDC: 66915-604-21	30 g in 1 BOTTLE
10	NDC: 66915-604-30	30 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/02/2013

Labeler - CoValence, Inc. (070653204)

Establishment
Name	Address	ID/FEI	Business Operations
CoValence, Inc		070653204	manufacture(66915-604)