Label: MOROCCANOIL SPF 50- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 69942-050-01 - Packager: Moroccanoil, Inc.
- 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 December 15, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- PURPOSE
- ACTIVE INGREDIENTS
- USES
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DIRECTIONS
Shake bottle before use.
Apply liberally over clean skin 15 minutes before sun exposure.
Reapply:
-- After 40 minutes of swimming or sweating.
-- Immediately after towel-drying.
-- At least every 2 hours.
Protect this product from excessive heat and direct sun.
Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To help prevent this risk, regularly use a sunscreen with a broad spectrum SPF 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, hats and sunglasses.
Children under 6 months: Ask a doctor.
- KEEP OUT OF REACH OF CHILDREN
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WARNINGS
For external use only.
Do not use on damaged or broken skin.
When using this product, keep out of eyes. In case of contact, rinse with water to remove.
Stop use and ask a doctor if rash occurs.
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right a way.
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INACTIVE INGREDIENTS
AQUA (WATER), C12-15 ALKYL BENZOATE, BUTYLOCTYL SALICYLATE, GLYCERIN, CYCLOPENTASILOXANE, POLYESTER-7, HYDROGENATED DIMER DILINOLEYL/DIMETHYLCARBONATE COPOLYMER, NEOPENTYL GLYCOL DIHEPTANOATE, DIMETHICONE, TRIMETHYLSILOXYSILICATE, PARFUM (FRAGRANCE), ARGANIA SPINOSA KERNEL OIL, BENZOTRIAZOLYL DODECYL P-CRESOL, COCOS NUCIFERA (COCONUT) OIL, TOCOPHERYL ACETATE, SOYBEAN GLYCERIDES, GARDENIA TAHITENSIS FLOWER EXTRACT, TOCOPHEROL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, LAURYL GLUCOSIDE, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER, POLYBUTENE, XANTHAN GUM, CITRIC ACID, POTASSIUM SORBATE, METHYLISOTHIAZOLINONE.
- QUESTIONS OR COMMENTS?
- PACKAGING
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INGREDIENTS AND APPEARANCE
MOROCCANOIL SPF 50
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69942-050 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 OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.7 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL Inactive Ingredients Ingredient Name Strength ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X) COCONUT OIL (UNII: Q9L0O73W7L) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y) TOCOPHEROL (UNII: R0ZB2556P8) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) XANTHAN GUM (UNII: TTV12P4NEE) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) POLYESTER-7 (UNII: 0841698D2F) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) SOYBEAN OIL (UNII: 241ATL177A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69942-050-01 1 in 1 BOX 06/01/2015 1 150 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/01/2015 Labeler - Moroccanoil, Inc. (964352202) Registrant - Moroccanoil, Inc. (964352202)
