Label: NATURAL SUN AQ BODY AND FAMILY MILD SUN MILK- octinoxate, octisalate, titanium dioxide, avobenzone, enzacamene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51523-101-01, 51523-101-02 - Packager: THEFACESHOP CO., LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated November 29, 2010
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ACTIVE INGREDIENT
OCTINOXATE (7.50%)
OCTISALATE (3.00%)
TITANIUM DIOXIDE (2.34%)
AVOBENZONE (2.30%)
ENZACAMENE (2.00%)WATER · CYCLOMETHICONE · GLYCERIN · DIPROPYLENE GLYCOL · DICAPRYLYL CARBONATE · OCTYLDODECYL NEOPENTANOATE · POTASSIUM CETYL PHOSPHATE · SORBITAN MONOSTEARATE · GLYCERYL MONOSTEARATE · POLYOXYL 100 STEARATE · DIMETHICONE · CETEARYL ALCOHOL · COPTIS · MINERAL OIL ·XANTHAN GUM · STEARIC ACID · ALOE FEROX LEAF · SILICON DIOXIDE · EDETATE DISODIUM · IONONE · BENZYL BENZOATE · BUTYLPHENYL METHYLPROPIONAL · .ALPHA.-HEXYLCINNAMALDEHYDE
- PURPOSE
- WHEN USING
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- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NATURAL SUN AQ BODY AND FAMILY MILD SUN MILK
octinoxate, octisalate, titanium dioxide, avobenzone, enzacamene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51523-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3 mL in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.34 mL in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.3 mL in 100 mL ENZACAMENE (UNII: 8I3XWY40L9) (ENZACAMENE - UNII:8I3XWY40L9) ENZACAMENE 2 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE (UNII: NMQ347994Z) GLYCERIN (UNII: PDC6A3C0OX) DIPROPYLENE GLYCOL (UNII: E107L85C40) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLYOXYL 100 STEARATE (UNII: YD01N1999R) DIMETHICONE (UNII: 92RU3N3Y1O) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) MINERAL OIL (UNII: T5L8T28FGP) XANTHAN GUM (UNII: TTV12P4NEE) STEARIC ACID (UNII: 4ELV7Z65AP) EDETATE DISODIUM (UNII: 7FLD91C86K) BENZYL BENZOATE (UNII: N863NB338G) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51523-101-02 1 in 1 BOX 1 NDC:51523-101-01 120 mL in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/22/2010 Labeler - THEFACESHOP CO., LTD (688329416) Registrant - THEFACESHOP CO., LTD (688329416) Establishment Name Address ID/FEI Business Operations THEFACESHOP CO., LTD 688329416 manufacture