Label: REEF KIDS SPF 30 OXYBENZONE FREE- octocrylene, octisalate, and avobenzone lotion
- NDC Code(s): 52854-513-01
- Packager: Tropical Seas, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 1, 2024
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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
- 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
aqueous extracts of: aloe barbadensis leaf extract, algae extract (hawaiian seaplant), chamomilla recutita (matricaria) flower extract, symphytum officinale (comfrey) root & leaf extract, taraxacum officinale (dandelion) leaf extract, echinacea purpurea (coneflower) extract, sambucus nigra (elder) flower extract, panax quinquefolium (ginseng) root extract, macrocystis pyrifera (kelp) extract, lavandula angustifolia (lavender) extract, cymbopogon schoenanthus (lemon grass) extract, althea officinalis (marshmallow) root extract, achillea millefolium (yarrow flower) extract, camellia sinensis (white tea) extract, phenethyl benzoate, octyl dodecyl citrate crosspolymer, stearic acid (vegetable derived), glyceryl stearate se (vegetable derived), cetyl dimethicone, glycerin (coconut derived), sodium hydroxide, emulsifying wax (vegetable derived), tricontanyl-pvp, polyethylene, acrylates/c10-30 alkyl acrylates cross-polymer, cetyl alcohol (vegetable derived), methylparaben, diazolidinyl urea, propylparaben, and caprylyl glycol.
- Other Information
- Questions or comments?
- Principal Display Panel - 120 mL Bottle Label
-
INGREDIENTS AND APPEARANCE
REEF KIDS SPF 30 OXYBENZONE FREE
octocrylene, octisalate, and avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52854-513 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) CARRAGEENAN (UNII: 5C69YCD2YJ) CHAMOMILE (UNII: FGL3685T2X) SYMPHYTUM UPLANDICUM LEAF (UNII: D05HXK6R3G) COMFREY ROOT (UNII: M9VVZ08EKQ) TARAXACUM OFFICINALE LEAF (UNII: 0022LFJ74Y) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) AMERICAN GINSENG (UNII: 8W75VCV53Q) MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4) LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P) CYMBOPOGON SCHOENANTHUS TOP (UNII: 9SJI1LW39W) ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H) ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PHENETHYL BENZOATE (UNII: 0C143929GK) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) CETYL DIMETHICONE 150 (UNII: 5L694Y0T22) GLYCERIN (UNII: PDC6A3C0OX) SODIUM HYDROXIDE (UNII: 55X04QC32I) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYSORBATE 60 (UNII: CAL22UVI4M) TRICONTANYL POVIDONE (UNII: N0SS3Q238D) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) CETYL ALCOHOL (UNII: 936JST6JCN) METHYLPARABEN (UNII: A2I8C7HI9T) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52854-513-01 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/01/2017 Labeler - Tropical Seas, Inc. (627865660) Establishment Name Address ID/FEI Business Operations Tropical Seas, Inc. 627865660 manufacture(52854-513)
