Label: HEB SPF 50 POMEGRANATE CONTINUOUS- avobenzone, homosalate, octisalate, octocrylene spray
- NDC Code(s): 37808-076-37
- Packager: H.E.B
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 February 26, 2023
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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 if
- 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 value of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. - 2 p.m.
• wearl long-sleeved shirts, pants, hats, and sunglasses
- Other Information
- Inactive Ingredients
- Label
-
INGREDIENTS AND APPEARANCE
HEB SPF 50 POMEGRANATE CONTINUOUS
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-076 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 100 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 40 mg in 1 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) GLYCERIN (UNII: PDC6A3C0OX) STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) PANTHENOL (UNII: WV9CM0O67Z) PODOPHYLLUM (UNII: 2S713A4VP3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37808-076-37 156 g in 1 CAN; Type 0: Not a Combination Product 02/07/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 02/07/2020 Labeler - H.E.B (007924756)
