Label: RADICAL SKINCARE SKIN PERFECTING SCREEN SPF 30- zinc oxide, titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 62510-001-40 - Packager: RADICAL BEAUTY USA INC
- Category: HUMAN OTC DRUG LABEL
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 March 31, 2015
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- SPL UNCLASSIFIED SECTION
- Active Ingredients:
- Purpose
- Uses
- Warnings
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Directions
- apply liberally 15 minutes before sun exposure
- reapply:
- after 40 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 wish 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-sleeved shirts, pants, hats and sunglasses
- children under 6 months: Ask a doctor
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Inactive Ingredients
Water, Caprylyl Methicone, PEG-10 Dimethicone, Isododecane, Titanium Dioxide, Alcohol, Caprylic/Capric Triglyceride, Polymethylsilsesquioxane, Methyl Methacrylate Crosspolymer, Sea Salt, Alumina, Methicone, Polyhydroxystearic Acid, Phenoxyethanol, Mica, Disodium EDTA, PEG-10, Glycerin, Isostearic Acid, Iron Oxides, Adenosine, Lecithin, Ascorbyl Tetraisopalmitate, Niacinamide, Tocopherol, Diamond Powder, Allantoin, Xanthum Gum, Camellia Sinensis Leaf Extract, Coffee Arabica (Coffee) Seed Extract, Pentylene Glycol, Superoxide Dismutase, Tromethamine
- Other information
- Questions or comments?
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Principal Label
RADICAL skincare
SKIN PERFECTING
SCREEN
SPF 30Non-Chemical Sunscreen
UV Broad Spectrum
High ProtectionTRYLACEL ™
40mL 1.35 FL. OZ.
For all skin types.
The perfect partner of any Radical regimen, this lightweight matte lotion offers non-chemical sunscreen with high sunburn protection, and light diffusing pigments to visibly reduce the appearance of wrinkles and imperctions, a hint of tint for the perfect healthy radiance.
Shake well before use.
Use over moisturizer, prior to sun exposure. Keep out of eyes. Stop use if irritation occurs or increases. If irritation persists, consult a health care practitioner.RADICAL BEAUTY
20 rue Cambon
75001 PARIS - FRANCE
made in France
www.radicalskincare.com -
INGREDIENTS AND APPEARANCE
RADICAL SKINCARE SKIN PERFECTING SCREEN SPF 30
zinc oxide, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62510-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 77.5 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 58.7 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) ISODODECANE (UNII: A8289P68Y2) ALCOHOL (UNII: 3K9958V90M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SEA SALT (UNII: 87GE52P74G) ALUMINUM OXIDE (UNII: LMI26O6933) PHENOXYETHANOL (UNII: HIE492ZZ3T) MICA (UNII: V8A1AW0880) EDETATE DISODIUM (UNII: 7FLD91C86K) POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y) GLYCERIN (UNII: PDC6A3C0OX) ISOSTEARIC ACID (UNII: X33R8U0062) FERRIC OXIDE RED (UNII: 1K09F3G675) ADENOSINE (UNII: K72T3FS567) ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A) NIACINAMIDE (UNII: 25X51I8RD4) TOCOPHEROL (UNII: R0ZB2556P8) DIAMOND (UNII: 6GRV67N0U2) ALLANTOIN (UNII: 344S277G0Z) XANTHAN GUM (UNII: TTV12P4NEE) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PENTYLENE GLYCOL (UNII: 50C1307PZG) TROMETHAMINE (UNII: 023C2WHX2V) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62510-001-40 1 in 1 CARTON 1 40 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/10/2014 Labeler - RADICAL BEAUTY USA INC (078605226) Registrant - Alban Muller International (647908011)