Label: CLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL- octinoxate, octocrylene, oxybenzone, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 53863-124-01, 53863-124-02 - Packager: Exelencia importers
- 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 February 23, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS AND PRECAUTIONS
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DOSAGE & ADMINISTRATION
Directions
- Apply liberally 15 minutes before sun exposure
- Reapply at least every 2 hours
- Children under 6 month: 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 value of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 AM - 2 PM
- Wear long-sleeved shirts, pants, hats, and sunglasses
- Use a water resistanct sunscreen if swimming or sweating
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INACTIVE INGREDIENT
Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, BHT, Butyrospermun Parkii (Shea Butter) Etract, Calcium Disodium EDTA, Caprylic/Capric Triglyceride, Cetaryl Alcohol (and) Ceteareth-20, Cyclomethicone, Cyclopentasiloxane, Diethylamino Hydroxybenzoyl Hexyl Beanzoate, Dimethicone, DMDM Hydantoin, Ectoin, Fragrance (Parfum), Glyceryl Stearate SE, Hamamelis Virginiana (Witch Hazel) Extract, Iron Oxides (C.I. 77.491/77.492/77.499), Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium DNA, Tocopheryl Acetate, Water (Aqua), Xanthan Gum, Yeast Extract (Saccharomyces Cerevisiae Extract)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLARIFYING LINE BROAD SPECTRUM SPF 50 EXEL
octinoxate, octocrylene, oxybenzone, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53863-124 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 8 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 3 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3 g in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SHEANUT OIL (UNII: O88E196QRF) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CYCLOMETHICONE (UNII: NMQ347994Z) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) DIMETHICONE (UNII: 92RU3N3Y1O) DMDM HYDANTOIN (UNII: BYR0546TOW) ECTOINE (UNII: 7GXZ3858RY) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53863-124-02 1 in 1 CARTON 1 NDC:53863-124-01 100 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/23/2015 Labeler - Exelencia importers (147644335) Registrant - Exelencia importers (147644335) Establishment Name Address ID/FEI Business Operations Biocosmetica Exel Argentina SRL 971813332 manufacture(53863-124)