drug facts

drug facts
SPL v2
SPL
SPL Set ID 9864a28d-80f6-4415-bd87-093132c05e74
Route
topical
Published
Effective Date 2013-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octinoxate (7.5 g) oxybenzone (4.5 g)
Inactive Ingredients
methylparaben propylparaben water stearic acid sorbitan monostearate sorbitol glyceryl stearate se hydrogenated soybean oil isopropyl myristate trolamine benzyl alcohol dimethicone jojoba oil tocopherol edetate disodium aloe vera leaf imidurea

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2013-07-17

Purpose

Sunscreen

Description

Octinoxate     7.5% Oxybenzone   4.5%


Medication Information

Warnings

For external use only



Uses
  • helps prevent suburn
  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of activity in water

Purpose

Sunscreen

Directions
  • apply generously and evenly before sun exposure and as needed
  • children under 6 months of age: ask a doctor
  • reapply frequently and after towel drying, swimming or perspiring

Other Information
  • may stain some fabrics

  • Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun

Inactive Ingredients

Water, Stearic Acid, Sorbitan Oleate, Sorbitol, Glyceryl Stearate SE, Hydrogenated Soybean Oil, Isopropyl Myristate, Triethanolamine, VP/Eicosene Copolymer, Benzyl Alcohol, Dimethicone, Carbomer, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol, Disodium EDTA, Aloe Barbadensis Leaf Juice, Imidazolidinyl Urea, Methylparaben, Propylparaben, Fragrance.



Description

Octinoxate     7.5% Oxybenzone   4.5%

Principal Display Panel

meijer

Sunscreen lotion

hypoallergenic

very water resistant

spf 15

Moisturizing

w/Aloe and Vitamin E

UVA/UVB Protection

10 FL. OZ. (296 mL)









Section 50565-1

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



Active Ingredients

Octinoxate     7.5%

Oxybenzone   4.5%



When Using This Product
  • keep out of eyes. Rinse with water to remove

Stop Use and Ask A Doctor If
  • rash or irritation develops and lasts


Structured Label Content

Warnings

For external use only



Uses
  • helps prevent suburn
  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of activity in water

Purpose

Sunscreen

Directions
  • apply generously and evenly before sun exposure and as needed
  • children under 6 months of age: ask a doctor
  • reapply frequently and after towel drying, swimming or perspiring

Other Information (Other information)
  • may stain some fabrics

  • Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun

Inactive Ingredients (Inactive ingredients)

Water, Stearic Acid, Sorbitan Oleate, Sorbitol, Glyceryl Stearate SE, Hydrogenated Soybean Oil, Isopropyl Myristate, Triethanolamine, VP/Eicosene Copolymer, Benzyl Alcohol, Dimethicone, Carbomer, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol, Disodium EDTA, Aloe Barbadensis Leaf Juice, Imidazolidinyl Urea, Methylparaben, Propylparaben, Fragrance.



Principal Display Panel

meijer

Sunscreen lotion

hypoallergenic

very water resistant

spf 15

Moisturizing

w/Aloe and Vitamin E

UVA/UVB Protection

10 FL. OZ. (296 mL)









Section 50565-1 (50565-1)

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



Active Ingredients (Active ingredients)

Octinoxate     7.5%

Oxybenzone   4.5%



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 or irritation develops and lasts


Advanced Ingredient Data


Raw Label Data

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