Label: H.E.B SOLUTIONS SUNSCREEN- ultra spf 100 continuous spray aerosol, spray
- NDC Code(s): 37808-982-37
- Packager: H.E.B
- 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 March 10, 2020
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- FLAMMABLE:
- DO NOT USE
- WHEN USING
- ASK 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
- children under 6 months of age: ask a doctor
- 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.
• wear long-sleeve shirts, pants, hats, and sunglasses
- Other information
-
Inactive ingredients
SD alcohol 40-B, butyloctyl salicylate, butylated PVP, polyester-10, propylene glycol dibenzoate, glycerin, caprylic/capric triglyceride, tocopherol, aloe barbadensis leaf juice, saccharomyces/podophyllum peltatum ferment filtrate, chamomilla recutita (matricaria) flower extract, camellia sinensis leaf extract (green tea), fragrance, propylene glycol, butylene glycol
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
H.E.B SOLUTIONS SUNSCREEN
ultra spf 100 continuous spray aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-982 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 150 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 60 mg in 1 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ALOE VERA LEAF (UNII: ZY81Z83H0X) TOCOPHEROL (UNII: R0ZB2556P8) GLYCERIN (UNII: PDC6A3C0OX) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYESTER-10 (UNII: 212N9O2MMZ) PROPYLENE GLYCOL DIBENZOATE (UNII: EQY32Z1AN4) CHAMOMILE (UNII: FGL3685T2X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37808-982-37 156 g in 1 CAN; Type 0: Not a Combination Product 01/20/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/20/2012 Labeler - H.E.B (007924756) Registrant - Fruit of the Earth, Inc. (079559467) Establishment Name Address ID/FEI Business Operations Fruit of the Earth, Inc. 008193513 manufacture(37808-982)