SONAGE PROTEC PLUS SPF 30 MINERAL SUNSCREEN- zinc oxide lotion

Sonage Protec Plus SPF 30 Mineral Sunscreen by

Drug Labeling and Warnings

Sonage Protec Plus SPF 30 Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by ASA Universal Inc. dba: Sonage. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide - 15.7%

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.

Warning

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 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

Reapply immediately after towel drying

Rapply at least every 2 hours.

Children under 6 monts: Ask a doctor.

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 value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. to 2 p.m. Wear long-sleeved shirts, pants, hats, and sun glasses.

Inactive Ingredients

aloe barbadensis leaf juice, arachidyl alcohol, arachidyl glucoside, behenyl alcohol, bisabolol*, butyloctyl salicylate, butyrospermum parkii (shea) butter*, caprylhydroxamic acid, capryloyl glycerin/sebacic acid copolymer, caprylyl glycol, cellulose gum, cetearyl alcohol, cetyl alcohol, citric acid, coco-glucoside, cocos nucifera (coconut) oil, diheptyl succinate, glycerin, microcrystalline cellulose, polyhydroxystearic acid, sodium gluconate, sodiumhyaluronate, sodium stearoyl glutamate, theobroma cacao (cocoa) seed butter* , tocopherol, water
*certified organic

Other Information

Protect this product from excessive heat and direct sun.

Carton

Tube

INGREDIENTS AND APPEARANCE

SONAGE PROTEC PLUS SPF 30 MINERAL SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69546-322
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15.7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LEVOMENOL (UNII: 24WE03BX2T)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO GLUCOSIDE (UNII: ICS790225B)
COCONUT OIL (UNII: Q9L0O73W7L)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SODIUM GLUCONATE (UNII: R6Q3791S76)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
DOCOSANOL (UNII: 9G1OE216XY)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SHEA BUTTER (UNII: K49155WL9Y)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
COCOA BUTTER (UNII: 512OYT1CRR)
WATER (UNII: 059QF0KO0R)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69546-322-02	50 mL in 1 TUBE; Type 0: Not a Combination Product	02/25/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/25/2022

Labeler - ASA Universal Inc. dba: Sonage (054687895)