Label: VACATION SPF 30 CHARDONNAY OIL- avobenzone, homosalate, octisalate, octocrylene oil
- NDC Code(s): 80641-008-01, 80641-008-02
- Packager: Vacation Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 March 10, 2023
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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: • 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 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, Butyrospermum Parkii (Shea) Oil, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Fragrance, Isopropyl Myristrate, Methyl Dihydroabietate, Passiflora Edulis (Passionfruit) Seed Oil, Polyester-8, Sclerocarya Birrea (Marula) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E),Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Vitis Vinifera (Chardonnay Grape) Seed Oil
- Other Information
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VACATION SPF 30 CHARDONNAY OIL
avobenzone, homosalate, octisalate, octocrylene oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80641-008 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 2.9 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) TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) JOJOBA OIL (UNII: 724GKU717M) TOCOPHEROL (UNII: R0ZB2556P8) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) SHEANUT OIL (UNII: O88E196QRF) PASSIFLORA EDULIS SEED OIL (UNII: F3VOA31UHQ) SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F) GRAPE SEED OIL (UNII: 930MLC8XGG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80641-008-01 100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2023 2 NDC:80641-008-02 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 01/01/2023 Labeler - Vacation Inc. (117644631)
