Label: VACATION SPF 30 BABY OIL- avobenzone, homosalate, octisalate, octocrylene oil
- NDC Code(s): 80641-011-01, 80641-011-03
- Packager: Vacation Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 6, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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Directions
• Apply liberally 15 minutes before sun exposure.
• Reapply at least every 2 hours• Use a water-resistant sunscreen if swimming or sweating.
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 a.m. - 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses • Children under 6 months of age: ask a physician.
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INACTIVE INGREDIENT
Bisabolol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calendula Officinalis Flower Extract, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Myristate, Jasminum Officinale (Jasmine) Extract, Methyl Dihydroabietate, Polyester-8, Rosa Canina (Rose) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Trimethylpentanediol/ Adipic Acid/Glycerin Crosspolymer
- Other Information
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VACATION SPF 30 BABY OIL
avobenzone, homosalate, octisalate, octocrylene oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80641-011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9.8 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.9 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.8 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 9.5 g in 100 mL Inactive Ingredients Ingredient Name Strength LEVOMENOL (UNII: 24WE03BX2T) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q) MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02) SUNFLOWER OIL (UNII: 3W1JG795YI) JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) ROSA CANINA SEED OIL (UNII: MHT97MG5P8) JOJOBA OIL (UNII: 724GKU717M) TOCOPHEROL (UNII: R0ZB2556P8) SAFFLOWER OIL (UNII: 65UEH262IS) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80641-011-01 100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2023 2 NDC:80641-011-03 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/01/2023 Labeler - Vacation Inc. (117644631)
