Spf30 Sunblock Stick

Spf30 Sunblock Stick
SPL v3
SPL
SPL Set ID e9f963ee-a98c-efc1-e053-2a95a90aaf53
Route
TOPICAL
Published
Effective Date 2022-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (4 g) Avobenzone (1.5 g) Homosalate (2 g) Octisalate
Inactive Ingredients
Mineral Oil Ceresin Butylated Hydroxytoluene Ethylhexyl Palmitate Microcrystalline Wax Phenoxyethanol Petrolatum Yellow Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-01

Description

Avobenzone 1.5% Homosalate 4% Octisalate 2% Octocrylene 4%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 1.5% Homosalate 4% Octisalate 2% Octocrylene 4%

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.
Section 50565-1

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

Section 51945-4

Warnings

For external use only.

Directions

Apply liberally 15-20 minutes before sun exposure. Reapply as needed or after towel drying, swimming or perspiring. Children under 6 months of age: ask a doctor.

Active Ingredient

Avobenzone 1.5%

Homosalate 4%

Octisalate 2%

Octocrylene 4%

Other Information:

Store at 20-25 oC (68-77 oF).

Inactive Ingredients:

Paraffinum liquidum, Petrolatum, Ozokerite, Ethylhexyl Palmitate, beeswax, Microcrystalline Wax, Phenoxyethanol, Fragrance, BHT


Structured Label Content

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.
Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only.

Directions

Apply liberally 15-20 minutes before sun exposure. Reapply as needed or after towel drying, swimming or perspiring. Children under 6 months of age: ask a doctor.

Active Ingredient (Active ingredient)

Avobenzone 1.5%

Homosalate 4%

Octisalate 2%

Octocrylene 4%

Other Information: (Other information:)

Store at 20-25 oC (68-77 oF).

Inactive Ingredients: (Inactive ingredients:)

Paraffinum liquidum, Petrolatum, Ozokerite, Ethylhexyl Palmitate, beeswax, Microcrystalline Wax, Phenoxyethanol, Fragrance, BHT


Advanced Ingredient Data


Raw Label Data

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