Label: OP PROTECT AND NOURISH BABIES AND SENSITIVE SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 70281-215-24 - Packager: SolSkyn Personal Care LLC
- 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 February 15, 2018
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Active Ingredients
- Active Ingredients
- Active Ingredients
- Purpose
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Uses
• Helps prevent sunburn.
• If used as directed with other sun protection measures (see Directions), decreases 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.
• Re-apply:
• after 80 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 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
• Children under 6 months: ask a doctor.
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Inactive Ingredients
Acrylates / C10-30 Alkyl Acrylate Crosspolymer, Acrylates Copolymer, Carbomer, Cholecalciferol, Diisopropyl Adipate, Dimethyl Capramide, Disodium EDTA, Hydroxypropyl Methylcellulose, Idopropynyl Butylcarbamate, Macrocystis Pyrifera Extract, Phenoxyethanol, Polyester-8, Propylene Glycol, Sorbitan Oleate, Tocopheryl Acetate, Triethanolamine, Water
- Other Information:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OP PROTECT AND NOURISH BABIES AND SENSITIVE SPF 50
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70281-215 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7 g in 100 g Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) CHOLECALCIFEROL (UNII: 1C6V77QF41) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) HYPROMELLOSES (UNII: 3NXW29V3WO) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70281-215-24 227 g in 1 CONTAINER; Type 0: Not a Combination Product 09/15/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 09/15/2015 Labeler - SolSkyn Personal Care LLC (080010329) Establishment Name Address ID/FEI Business Operations KIK Custom Products – Rexdale plant 243547333 ANALYSIS(70281-215) , MANUFACTURE(70281-215)
