Label: MOISTURIZING TINT SPF 30- octinoxate, octisalate, oxybenzone, avobenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 60541-0706-7 - Packager: Hayden Caleel LLC
- 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 1, 2014
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients:
- Purpose:
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Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), helps decrease the risk of skin cancer and early skin aging caused by the sun
- Warnings
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Directions
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
- Children under 6 months of age: Ask a doctor
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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 a.m. – 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
- Other information
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Inactive ingredients
Aqua (Water/Eau)
Isoeicosane
Potassium Cetyl Phosphate
Cetearyl Alcohol
Cetyl Dimethicone
Dimethicone
Ethyhexyl Methoxycrylene
Glycerin
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer
Silica
Sorbitan Sesquioleate
Isohexadecane
Phenoxyethanol
Caprylyl Glycol
Ethylhexylglycerin
Polysorbate 60
Hexylene Glycol
Citric Acid
MAY CONTAIN (+/-):
Titanium Dioxide (CI 77891)
Iron Oxides (CI 77491, CI 77492, CI 77499)
- Principal Display Panel - 50mL Carton Label
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INGREDIENTS AND APPEARANCE
MOISTURIZING TINT SPF 30
octinoxate, octisalate, oxybenzone, avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60541-0706 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 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 5 g in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 4 g in 1 mL Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 3 g in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Isoeicosane (UNII: AR294KAG3T) Potassium Cetyl Phosphate (UNII: 03KCY6P7UT) Cetostearyl Alcohol (UNII: 2DMT128M1S) Cetyl Dimethicone 45 (UNII: IK315POC44) Dimethicone (UNII: 92RU3N3Y1O) Ethylhexyl Methoxycrylene (UNII: S3KFG6Q5X8) Glycerin (UNII: PDC6A3C0OX) Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.S At 1%) (UNII: 86FQE96TZ4) Silicon Dioxide (UNII: ETJ7Z6XBU4) Sorbitan Sesquioleate (UNII: 0W8RRI5W5A) Isohexadecane (UNII: 918X1OUF1E) Phenoxyethanol (UNII: HIE492ZZ3T) Caprylyl Glycol (UNII: 00YIU5438U) Ethylhexylglycerin (UNII: 147D247K3P) Polysorbate 60 (UNII: CAL22UVI4M) Hexylene Glycol (UNII: KEH0A3F75J) Citric Acid Monohydrate (UNII: 2968PHW8QP) Titanium Dioxide (UNII: 15FIX9V2JP) Ferric Oxide Red (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60541-0706-7 1 in 1 BOX 1 50 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2014 Labeler - Hayden Caleel LLC (011367468) Establishment Name Address ID/FEI Business Operations Hayden Caleel LLC 011367468 MANUFACTURE(60541-0706)
