Label: FRUIT OF THE EARTH, INC. LUV THAT SUN SPF 30 CONTINUOUS- avobenzone, homosalate, octisalate, octocrylene aerosol, spray
- NDC Code(s): 62217-827-25
- Packager: Fruit of the Earth, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 December 21, 2022
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- FLAMMABLE:
- Do not use
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children.
-
Directions
- apply liberally 15 minutes before sun exposure
- hold can 4-6 inches away from body, spray evenly to ensure
complete coverage
- do not spray into face. Spray into hand and apply to face.
- use in well ventilated, but not windy areas
- 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 value 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-sleeved shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
- Other information
-
Inactive ingredients
SD Alcohol 40-B, Butyloctyl Salicylate, Acrylates/Octylacrylamide
Copolymer, Hibiscus Sabdariffa Flower Extract, Pyrus Malus (Apple) Fruit
Extract, Citrullus Lanatus (Watermelon) Fruit Extract, Lens Esculenta
(Lentil) Fruit Extract, Adansonia Digitata Fruit Extract, Scutellaria Alpina
Flower/Leaf/Stem Extract, Trifolium Pratense (Clover) Leaf Extract,
Phragmites Communis Extract, Poria Cocos Extract, Camellia Sinensis
(Green Tea) Leaf Extract, Panthenol, Tocopherol, Fragrance, Diethylhexyl
Syringylidenemalonate, Stearoxytrimethylsilane, Caprylic/Capric
Triglyceride, Water, Glycerin, Polysorbate 20, Phenoxyethanol. - Label
-
INGREDIENTS AND APPEARANCE
FRUIT OF THE EARTH, INC. LUV THAT SUN SPF 30 CONTINUOUS
avobenzone, homosalate, octisalate, octocrylene aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62217-827 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 20 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2) TOCOPHEROL (UNII: R0ZB2556P8) WATER (UNII: 059QF0KO0R) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ADANSONIA DIGITATA FRUIT (UNII: 51N9TR1W6P) FU LING (UNII: XH37TWY5O4) APPLE (UNII: B423VGH5S9) TRIFOLIUM PRATENSE LEAF (UNII: 612YOZ36DG) ALCOHOL (UNII: 3K9958V90M) ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK) GLYCERIN (UNII: PDC6A3C0OX) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PANTHENOL (UNII: WV9CM0O67Z) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) WATERMELON (UNII: 231473QB6R) HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M) LENS CULINARIS FRUIT (UNII: ZYZ076G9JH) PHRAGMITES AUSTRALIS STEM (UNII: 3AW23L82V4) SCUTELLARIA ALPINA FLOWERING TOP (UNII: 68JZ9NK55M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62217-827-25 177 mL in 1 CAN; Type 0: Not a Combination Product 03/03/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/03/2016 Labeler - Fruit of the Earth, Inc. (079559467)