Label: REEF BABIES SPF 50 OXYBENZONE FREE- octocrylene, octisalate, and avobenzone spray
- NDC Code(s): 52854-558-02
- Packager: Tropical Seas, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 2, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
-
Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
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Directions
- apply liberally 15 minutes before sun exposure
- do not spray directly on face - spray into hands and apply to face
- hold approximately 4 - 6 inches from skin to spray
- rub into skin evenly to ensure appropriate coverage
- use in a well-ventilated area
- avoid inhaling or exposing others to spray
- do not apply in windy conditions
- 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 this risk, regularly use a sunscreen with a broad spectrum SPF 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: Ask a doctor
- Inactive Ingredients
- Other Information
- Questions or comments?
- Principal Display Panel - Bottle Label
-
INGREDIENTS AND APPEARANCE
REEF BABIES SPF 50 OXYBENZONE FREE
octocrylene, octisalate, and avobenzone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52854-558 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL Inactive Ingredients Ingredient Name Strength PHENETHYL BENZOATE (UNII: 0C143929GK) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) LAURYL LACTATE (UNII: G5SU0BFK7O) ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK) OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: X323T6QO4M) ALCOHOL (UNII: 3K9958V90M) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52854-558-02 180 mL in 1 CAN; Type 0: Not a Combination Product 12/07/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 12/07/2020 Labeler - Tropical Seas, Inc. (627865660) Establishment Name Address ID/FEI Business Operations Tropical Seas, Inc. 627865660 manufacture(52854-558)
