Label: HABIT SPF 38 CUCUMBER MISTER- avobenzone, homosalate, octisalate, octocrylene spray
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- NDC Code(s): 76150-333-69
- Packager: Bell International Laboratories, 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 January 1, 2022
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- Active Ingredient
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- Warnings
- KEEP OUT OF REACH OF CHILDREN
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Directions
Apply liberally and evenly 15 minutes before sun exposure
Reapply: after swimming or sweating, at least every 2 hours
Use a water-resistant sunscreen if swimming or sweating
Reapply after swimming or sweating
Sun Protection Meaures. 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 10a.m. - 2 p.m.
-wear long-sleeved shirts, pants, hats, and sunglasses.
Children under 6 monts-age: Ask a doctor
- Other Information
- Inactive Ingredients
- Package Label
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INGREDIENTS AND APPEARANCE
HABIT SPF 38 CUCUMBER MISTER
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76150-333 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.9 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.9 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9.8 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 9.5 g in 100 mL Inactive Ingredients Ingredient Name Strength DICAPRYL SUCCINATE (UNII: 8XD1ZF2M1M) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) DICAPRYLYL ETHER (UNII: 77JZM5516Z) LEVOMENOL (UNII: 24WE03BX2T) ETHYL FERULATE (UNII: 5B8915UELW) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) ALCOHOL (UNII: 3K9958V90M) DIHEPTYL SUCCINATE (UNII: 057N7SS26Y) CUCUMBER (UNII: YY7C30VXJT) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76150-333-69 26.6 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2022 Labeler - Bell International Laboratories, Inc (967781555)
