Label: ANTI-AGING TINTED MOISTURIZER BROAD SPECTRUM SPF 30- avobenzone, octinoxate, octisalate, oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 61016-0001-1 - Packager: Columbia Cosmetics Manufacturing, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 October 26, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children
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Directions
• apply liberally 15 minutes before sun exposure
• use a water-resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months: 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 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
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Inactive Ingredients
WATER (AQUA), ISOEICOSANE, POTASSIUM CETYL PHOSPHATE, CETEARYL ALCOHOL, CETYL DIMETHICONE, DIMETHICONE, ETHYHEXYL METHOXYCRYLENE, GLYCERIN, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SILICA,SORBITAN SESQUIOLEATE, ISOHEXADECANE, PHENOXYETHANOL, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, POLYSORBATE 60, HEXYLENE GLYCOL,TITANIUM DIOXIDE CI 77891, IRON OXIDES CI 77491, CI 77492, CI 77499.
- Other Information
- PRINCIPAL DISPLAY PANEL
- Anti-Aging Tinted Moisturizer Broad Spectrum SPF 30 45ml (61016-0001-1)
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INGREDIENTS AND APPEARANCE
ANTI-AGING TINTED MOISTURIZER BROAD SPECTRUM SPF 30
avobenzone, octinoxate, octisalate, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61016-0001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 mg in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mg in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mg in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 4 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOEICOSANE (UNII: AR294KAG3T) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) ISOHEXADECANE (UNII: 918X1OUF1E) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) POLYSORBATE 60 (UNII: CAL22UVI4M) HEXYLENE GLYCOL (UNII: KEH0A3F75J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61016-0001-1 45 mL in 1 TUBE; Type 0: Not a Combination Product 02/23/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/23/2012 Labeler - Columbia Cosmetics Manufacturing, Inc. (068267863) Establishment Name Address ID/FEI Business Operations Columbia Cosmetics Manufacturing, Inc. 068267863 manufacture(61016-0001)