Label: HAWAIIAN TROPIC - avobenzone, octocrylene and oxybenzone stick
- NDC Code(s): 63354-300-63
- Packager: Energizer Personal Care LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active Ingredients
helps prevent sunburnClose
- For external use only
- Do not use on damaged or broken skin
Keep out of reach of children
If product swallowed, get medical help or contact a Poison Control Center right away.
- apply liberally before sun exposure
- reapply after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every two hours
- Other Information
Sun Protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease theis 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-sleeve shirts, patns, hats and sunglasses
- Inactive Ingredients
Ozokerite, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Diisobutyl Adipate, Cetyl Alcohol, Cyclopentasiloxane, Theobroma Cacao (Cocoa) Seed Butter, Adipic Acid/Diglycol Crosspolymer, Dimethicone, Flavor, Isostearyl Linoleate, Cyclohexasiloxane, PEG-8, Silica, Sodium Saccharin, BHT, Mineral Oil, PEG-8 Dimethicone, Cocos Nucifera (Coconut) Oil, Aloe Barbadensis Leaf Extract, Carica Papaya (Papaya) Fruit Extract, Colocasia Antiquorum Root Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Octyldodecanol, Retinyl Palmitate, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Propylparaben.Close
- Questions or Comments?
Call 1-800-NO-UV RAY, Mon-FriClose
- Principal Display Panel
UVB & UVB
NET WT .14 OZ. (4 g)
- INGREDIENTS AND APPEARANCE
avobenzone, octocrylene, oxybenzone stick
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63354-300 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (AVOBENZONE) AVOBENZONE 1 g in 100 g OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 10 g in 100 g OXYBENZONE (OXYBENZONE) OXYBENZONE 6 g in 100 g Inactive Ingredients Ingredient Name Strength ETHYLHEXYL PALMITATE MEDIUM-CHAIN TRIGLYCERIDES DIISOBUTYL ADIPATE CETYL ALCOHOL CYCLOMETHICONE 5 CYCLOMETHICONE 6 DIMETHICONE POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM DIHYDRATE PROPYLPARABEN ALOE VERA LEAF BUTYLATED HYDROXYTOLUENE MINERAL OIL PAPAYA MANGO PLUMERIA RUBRA FLOWER COLOCASIA ESCULENTA ROOT GUAVA PASSIFLORA INCARNATA FRUIT VITAMIN A PALMITATE ASCORBIC ACID .ALPHA.-TOCOPHEROL ACETATE, DL- OCTYLDODECANOL SILICON DIOXIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-300-63 4 g in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/11/2012 Labeler - Energizer Personal Care LLC (021718141)