heb oil free facial moisturizer with sunscreen broad spectrum spf 15

heb oil free facial moisturizer with sunscreen broad spectrum spf 15
SPL v2
SPL
SPL Set ID f6ce4ea0-d92f-368c-e053-6294a90a2a81
Route
topical
Published
Effective Date 2021-02-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (15 mg) octisalate (50 mg) octocrylene (60 mg)
Inactive Ingredients
water glycerin edetate disodium cetostearyl alcohol phenoxyethanol caprylyl glycol sodium hydroxide ethylene brassylate peg-100 stearate hexamethyldisiloxane carbomer interpolymer type a (allyl sucrose crosslinked) butyloctyl salicylate octyldodecyl neopentanoate polysorbate 60 glyceryl 1-stearate 2,6-dimethyl-5-heptenal ethylhexylglycerin dipropylene glycol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-02-26

Purpose

Sunscreen

Description

Avobenzone 1.5%, Octisalate 5.0%, Octocrylene 6.0%


Medication Information

Warnings

For external use only

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see  Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
Purpose

Sunscreen

Directions
  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply 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

water, octyldodecyl neopentanoate, glycerin, cetearyl alcohol, polysorbate 60, butyloctyl salicylate, glyceryl stearate, PEG-100 stearate, dimethicone, phenoxyethanol, ethylhexylglycerin, caprylyl glycol, carbomer, sodium hydroxide, disodium EDTA, ethylene brassylate, dipropylene glycol, dimethyl heptenal

Description

Avobenzone 1.5%, Octisalate 5.0%, Octocrylene 6.0%

Label

do Not Use

• on damaged or broken skin.

active Ingredients

Avobenzone 1.5%, Octisalate 5.0%, Octocrylene 6.0%

when Using This Product

• keep out of eyes. Rinse with water to remove.

stop Use and Ask A Doctor If

• rash occurs.

keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings

For external use only

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see  Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
Purpose

Sunscreen

Directions
  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply 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 (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 (Inactive ingredients)

water, octyldodecyl neopentanoate, glycerin, cetearyl alcohol, polysorbate 60, butyloctyl salicylate, glyceryl stearate, PEG-100 stearate, dimethicone, phenoxyethanol, ethylhexylglycerin, caprylyl glycol, carbomer, sodium hydroxide, disodium EDTA, ethylene brassylate, dipropylene glycol, dimethyl heptenal

Label

do Not Use (Do not use)

• on damaged or broken skin.

active Ingredients (Active ingredients)

Avobenzone 1.5%, Octisalate 5.0%, Octocrylene 6.0%

when Using This Product (When using this product)

• keep out of eyes. Rinse with water to remove.

stop Use and Ask A Doctor If (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.


Advanced Ingredient Data


Raw Label Data

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