Label: HEB SPF 55 BABIES AND KIDS SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene stick
- NDC Code(s): 37808-908-01, 37808-908-28
- 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 23, 2023
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- 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
- 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.
• wear long-sleeved shirts, pants, hats, and sunglasses
- Other Information
- Inactive Ingredient(s)
- Label
-
INGREDIENTS AND APPEARANCE
HEB SPF 55 BABIES AND KIDS SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-908 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 Inactive Ingredients Ingredient Name Strength WHITE WAX (UNII: 7G1J5DA97F) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CETYL ALCOHOL (UNII: 936JST6JCN) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) COCOA BUTTER (UNII: 512OYT1CRR) PHENOXYETHANOL (UNII: HIE492ZZ3T) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) CERESIN (UNII: Q1LS2UJO3A) STEARYL BEHENATE (UNII: A68S9UI39D) LAURYL LACTATE (UNII: G5SU0BFK7O) POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37808-908-28 42 g in 1 CONTAINER; Type 0: Not a Combination Product 04/01/2019 2 NDC:37808-908-01 13.3 g in 1 CONTAINER; Type 0: Not a Combination Product 04/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 04/01/2019 Labeler - H.E.B. (007924756)
