![CALIFORNIA TAN SPF 15 SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE) LOTION [PRIME ENTERPRISES INC.]](https://medic.hrt.org//dailymed/images/38147f3c-9629-03bd-e054-00144ff88e88/58443-0169-4.jpg)
| NDC | 58443-0169-4 |
| Set ID | 38147f3c-9629-03bd-e054-00144ff88e88 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Prime Enterprises Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- Active Ingredients
- PURPOSE
- Uses
- WARNINGS
-
Directions
- apply liberally 15 minutes before sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- 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 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 INGREDIENT
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Adenosine Cyclic Phosphate, Adenosine Triphosphate, Butylphthalimide, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Cetyl Alcohol, Coleus Forskohlii Root Extract, Disodium EDTA, Fragrance (Parfum), Glucose, Hydrolyzed Soy Protein, Isopropylphthalimide, Lycium Barbarum (Goji Berry) Fruit Extract, Methylisothiazolinone, Micrococcus Lysate, Phenoxyethanol, Phenyl Trimethicone, Phospholipids, Plant Amino Acids, Polyethylene, Polyperfluoroethoxymethoxy Difluoroethyl PEG Phosphate, Polysilicone-15, Potassium Cetyl Phosphate, Potassium Hydroxide, Propylene Glycol, Pyruvic Acid, Saccharomyces/Calcium Ferment, Saccharomyces Lysate Extract, Saccharomyces/Magnesium Ferment, Saccharomyces/Zinc Ferment, Silica, Stearyl Alcohol, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Water (Aqua)
- Other Information
- Questions or Comments?
- California Tan SPF 15 Sunscreen Lotion
-
INGREDIENTS AND APPEARANCE
CALIFORNIA TAN SPF 15 SUNSCREEN
avobenzone, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0169 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 20 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 18.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength STEARYL ALCOHOL (UNII: 2KR89I4H1Y) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PYRUVIC ACID (UNII: 8558G7RUTR) AMINO ACIDS (UNII: 0O72R8RF8A) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) MICROCOCCUS LUTEUS (UNII: LV6L29Z6AX) LYCIUM BARBARUM FRUIT (UNII: 930626MWDL) ADENOSINE CYCLIC PHOSPHATE (UNII: E0399OZS9N) ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE) PHENOXYETHANOL (UNII: HIE492ZZ3T) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) POLYSILICONE-15 (UNII: F8DRP5BB29) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DEXTROSE (UNII: IY9XDZ35W2) (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CETYL ALCOHOL (UNII: 936JST6JCN) N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E) COLEUS FORSKOHLII ROOT OIL (UNII: 5NXR7DJ9WO) SOY PROTEIN (UNII: R44IWB3RN5) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329) WATER (UNII: 059QF0KO0R) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0169-4 133 mL in 1 TUBE; Type 0: Not a Combination Product 12/30/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/30/2015 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0169) , manufacture(58443-0169) , label(58443-0169) , analysis(58443-0169)
