Label: BARE REPUBLIC CLEARSCREEN SPF 30- sunscreen spray
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Contains inactivated NDC Code(s)
NDC Code(s): 79753-008-01 - Packager: COOLA LLC
- 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 November 20, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- Uses
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Warnings
For external use only
Flammable: Contents under pressure. Do not puncture or incinerate. Do not stroe at temperatures above 120 F. Do not use in the presence of a flame or spark, or while smoking.
Do not use on damaged or broken skin
When using this product keep away from face to avoid breathing in.
Keep out of eyes. Rinse with water to remove.
Apply outdoors. Avoid overspray as could cause surface to become slippery.
Do not apply in windy conditions.
Use in a well-ventilated area
Stop use and ask doctor if skin rash occurs
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Directions
Shake well
Apply liberally 15 minutes before sun exposure.
Hold container 4 to 6 inches from skin to apply
Rub in
Do not spray directly on faae. Spray onto hands and apply to face.
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 of 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10 a.m. - 2 p.m.
weare long-sleeve shirts, pants, hats, and sunglasses.
Children under 6 months: Ask a doctor
- Other Information
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Inactive ingredients
Alcohol Denat., Butyloctyl Salicylate, Dicaprylyl Carbonate, Diisopropyl Adipate, Ethylhexyl Methoxycrylene, Fragreance, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Linum Usitatissimum (Linseed) Seed Oil, Lycium Barbarum (Goji Berry) Fruit Extract, Methyl Dihydroabietate, Rosa Moschata Seed Oil, Rubus Idaeus (Raspberry) Fruit Extract, Tocopherol, VA/Butyl Maleate/Isobomyl Acrylate Copolymer, Vaccinum Myrtillus Fruit/Leaf Extract, Water
- Label
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INGREDIENTS AND APPEARANCE
BARE REPUBLIC CLEARSCREEN SPF 30
sunscreen sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) .GAMMA.-NONALACTONE (UNII: I1XGH66S8P) 4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) LINSEED OIL (UNII: 84XB4DV00W) TOCOPHEROL (UNII: R0ZB2556P8) SOYBEAN OIL (UNII: 241ATL177A) ROSA MOSCHATA SEED OIL (UNII: T031ZE559T) LYCIUM BARBARUM FRUIT (UNII: 930626MWDL) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) ALLYL HEPTANOATE (UNII: AU4CYG9V68) .GAMMA.-OCTALACTONE (UNII: UHD6M52X0K) PIPERONAL (UNII: KE109YAK00) LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P) APRICOT (UNII: 269CJD5GZ9) MANGO (UNII: I629I3NR86) CUCUMIS MELO ROOT (UNII: Q0C4GQY42G) RASPBERRY (UNII: 4N14V5R27W) APPLE (UNII: B423VGH5S9) CITRUS MAXIMA FRUIT RIND (UNII: 5NX3G75CA6) ALMOND (UNII: 3Z252A2K9G) ORANGE PEEL (UNII: TI9T76XD44) MENTHA X PIPERITA WHOLE (UNII: 79M2M2UDA9) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ALCOHOL (UNII: 3K9958V90M) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) BILBERRY (UNII: 9P2U39H18W) .GAMMA.-DECALACTONE (UNII: 7HLS05KP9O) IMPATIENS BALSAMINA FLOWER (UNII: 3169PS5TJH) VANILLA BEAN (UNII: Q74T35078H) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) CITRUS BERGAMIA LEAF (UNII: ZGS96VDV4T) SUNFLOWER OIL (UNII: 3W1JG795YI) VANILLIN (UNII: CHI530446X) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-008-01 177 mL in 1 CAN; Type 0: Not a Combination Product 11/02/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/02/2020 Labeler - COOLA LLC (956990290)
