Label: SPF 20 SUNSCREEN UVAUVB TINTED MOISTURIZER NUDE- octisalate cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 52664-633-01 - Packager: Hangzhou Facecare Cosmetics 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 December 10, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions:
For sunscreen use:
Apply generously 15 min before sun exposure.
Apply to clean skin in an upward and outward motion with sponage or foundation brush
Children under six months of age: ask a doctor.
Reapply at least every two hours.
Use a water resistant sunscreen if swimming or sweating
Sun Protection Measures:
Spending time in sun increases your risk of skin cancer or early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measures including
- Limit time in the sun, especially from 10 am to 2 pm
- Wear long sleeved shirts, pants, hats, and sunglasses.
- Children under six months of age: ask a doctor
Other Information:
Protect this product in the container from excessive heat and direct sun
Store at room temperature 15-30 C (59-86F)
-
INACTIVE INGREDIENT
Inactive Ingredient:
Water, Dimethicone, Propylene Glycol, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Steareth-21, Steareth-2, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Caprylyl Glycol, Ethylhexyglycerin, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Xantahn Gum, Retinyl Palmitate (VA), Ascorbyl Palmitate (VC), Tocopheryl Acetate (VE), Butylene Glycol, Aloe Barbadensis Leaf Extract, Cucumis Sativus (Cucumber) Fruit Extract
May contain:
Titanium Oxide, Iron Oxides (CI 77491, CI 77492, CI 77499)
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SPF 20 SUNSCREEN UVAUVB TINTED MOISTURIZER NUDE
octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52664-633 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 3 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) DIMETHICONE (UNII: 92RU3N3Y1O) STEARETH-21 (UNII: 53J3F32P58) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) XANTHAN GUM (UNII: TTV12P4NEE) VITAMIN A (UNII: 81G40H8B0T) ASCORBYL PALMITATE (UNII: QN83US2B0N) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CUCUMIS SATIVUS WHOLE (UNII: 50560UL2YV) STEARETH-2 (UNII: V56DFE46J5) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52664-633-01 25 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/19/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/19/2019 Labeler - Hangzhou Facecare Cosmetics Co., Ltd. (545341856) Registrant - Hangzhou Facecare Cosmetics Co., Ltd. (545341856) Establishment Name Address ID/FEI Business Operations Hangzhou Facecare Cosmetics Co., Ltd. 545341856 manufacture(52664-633)
