PROVENCE CALENDULA SUN- zinc oxide, titanium dioxide liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)

Available from:

NATURE REPUBLIC CO., LTD.

INN (International Name):

ZINC OXIDE

Composition:

ZINC CATION 6.24 mg in 50 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose: Sunscreen [UV Protection] HOW TO USE: Shake the product 3-5 times before use. Then evenly apply an appropriate amount on areas exposed to UV rays.

Authorization status:

OTC monograph not final

Summary of Product characteristics

PROVENCE CALENDULA SUN- ZINC OXIDE, TITANIUM DIOXIDE LIQUID
NATURE REPUBLIC CO., LTD.
_Disclaimer: 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._
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ACTIVE INGREDIENT
ACTIVE INGREDIENTS: ZINC OXIDE 12.48%, TITANIUM DIOXIDE 2.00%
INACTIVE INGREDIENT
INACTIVE INGREDIENTS: CYCLOPENTASILOXANE, WATER, ISODODECANE, BUTYLENE
GLYCOL,DICAPRYLYL ETHER,GLYCERIN,METHYL METHACRYLATE CROSSPOLYMER,
ALCOHOL,BIOSACCHARIDE GUM-1,CAPRYLYL
METHICONE,NIACINAMIDE,CAPRYLIC/CAPRIC/SUCCINIC TRIGLYCERIDE,PEG-10
DIMETHICONE,POLYMETHYLSILSESQUIOXANE,DIMETHICONE,MAGNESIUM
SULFATE,VISCUM ALBUM (MISTLETOE) LEAF EXTRACT,CENTELLA ASIATICA
EXTRACT,PORTULACA OLERACEA
EXTRACT,METHICONE,SILICA,PHENOXYETHANOL,POLYGLYCERYL-6
POLYRICINOLEATE,ALUMINUM HYDROXIDE,DIMETHICONE/VINYL DIMETHICONE
CROSSPOLYMER,FRAGRANCE,CAPRYLYL GLYCOL,STEARIC ACID,GLYCERYL
CAPRYLATE,TOCOPHERYL ACETATE,ADENOSINE,POLYURETHANE-11,CALENDULA
OFFICINALIS FLOWER EXTRACT
PURPOSE
Purpose: Sunscreen [UV Protection]
CAUTIONS
CAUTIONS: 1. For external use only. 2. Discontinue use if signs of
irritation or rashes appear. 3. Keep
out of reach of children 4. Replace the cap after use.
KEEP OUT OF REACH OF CHILDREN
KEEP OUT OF REACH OF CHILDREN
HOW TO USE
HOW TO USE: Shake the product 3-5 times before use. Then evenly apply
an appropriate amount on
areas exposed to UV rays.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PROVENCE CALENDULA SUN
zinc oxide, titanium dioxide liquid
PRODUCT INFORMATION
NATURE REPUBLIC CO., LTD.
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:51346 -28 7
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37)
ZINC CATION
6 .24 mg in 50 mL
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9
V2JP)
TITANIUM DIOXIDE
1.0 0 mg in 50 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATE