HEB BROAD SPECTRUM SPF 30 COCONUT SCENTED SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene stick

HEB BROAD SPECTRUM SPF 30 COCONUT SCENTED SUNSCREEN by

Drug Labeling and Warnings

HEB BROAD SPECTRUM SPF 30 COCONUT SCENTED SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by H.E.B. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 5.0%

Purpose

Sunscreen

Uses

helps prevent sunburn

Warnings

For external use only

DO NOT USE

Do not use  on damaged or broken skin.

WHEN USING

When using this product  keep out of eyes. Rinse with water to remove.

ASK DOCTOR

Stop use and ask a doctor if  rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

• protect the product in this container from excessive heat and direct sun
• may stain or damage some fabrics, materials or surfaces

Inactive ingredients

C12-15 alkyl benzoate, paraffin, butyloctyl salicylate, synthetic wax, ozokerite, euphorbia cerifera (candelilla) wax, dimethicone, aloe barbadensis leaf juice, mineral oil, ascorbyl palmitate, tocopheryl acetate, dimethicone crosspolymer-3, cetyl dimethicone, cetyl alcohol, caprylyl glycol.

Questions of comments?

Call toll free 1-800-527-7731

PRINCIPAL DISPLAY PANEL

NDC: 37808-931-89

NDC: 37808-931-58

INGREDIENTS AND APPEARANCE

HEB BROAD SPECTRUM SPF 30 COCONUT SCENTED SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-931
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 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CANDELILLA WAX (UNII: WL0328HX19)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PARAFFIN (UNII: I9O0E3H2ZE)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CERESIN (UNII: Q1LS2UJO3A)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETYL ALCOHOL (UNII: 936JST6JCN)
MINERAL OIL (UNII: T5L8T28FGP)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-931-89	2 in 1 CARTON	04/03/2019
1	NDC: 37808-931-58	0.15 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/03/2019

Labeler - H.E.B (007924756)

Registrant - Fruit of the Earth, Inc. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(37808-931)