Label: 4-IN-1 BROAD SPECTRUM SPF 50 SUNSCREEN- avobenzone, homosalate, octocrylene, octisalate, oxybenzone cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 80030-001-01 - Packager: Bio Jouvance
- 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 August 19, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Uses
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
- apply liberally 15 minutes before sun exposure
- re-apply:
- after 40 minutes of swimming or sweating
- immediately after towel drying
- at least every two hours
- Sun Protection Meaures. Spending time under the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regurlarly use a sunscreen with an SPF of 15 or higher, and other sun protection meaures, including:
- limit time under the sun, especially from 10:00 a.m. to 2:00 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a Physician if exposure would be advised.
-
INACTIVE INGREDIENT
water, stearic acid, glyceryl stearate, PEG-100 stearate, elaeis guineensis kernel oil, aloe barbadensis leaft ectract, retinyl palmitate, pyridoxine hydrochloride cyanocobalamin, ascorbic acid, tocopheryl acetate, sodium hyaluronate crosspolymer, dimethicone, polysorbate 60, carbomer, triethanolamine, DMDM hydantoin, diazolidinyl urea, iodopropynyl butylcarbamate
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
4-IN-1 BROAD SPECTRUM SPF 50 SUNSCREEN
avobenzone, homosalate, octocrylene, octisalate, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80030-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 8 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL Inactive Ingredients Ingredient Name Strength PEG-100 STEARATE (UNII: YD01N1999R) ASCORBIC ACID (UNII: PQ6CK8PD0R) WATER (UNII: 059QF0KO0R) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) TROLAMINE (UNII: 9O3K93S3TK) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) STEARIC ACID (UNII: 4ELV7Z65AP) PALM KERNEL OIL (UNII: B0S90M0233) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) POLYSORBATE 60 (UNII: CAL22UVI4M) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ALOE VERA LEAF (UNII: ZY81Z83H0X) PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) DMDM HYDANTOIN (UNII: BYR0546TOW) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) CYANOCOBALAMIN (UNII: P6YC3EG204) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) DIMETHICONE (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80030-001-01 60 mL in 1 TUBE; Type 0: Not a Combination Product 08/19/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/19/2020 Labeler - Bio Jouvance (013516194) Establishment Name Address ID/FEI Business Operations Cosmetic Science Laboratories, LLC 018454384 manufacture(80030-001)
