SPL v1
SPL
SPL Set ID cffd82fe-c05a-58df-e053-2995a90acd21
Route
TOPICAL
Published
Effective Date 2021-11-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (22.75 g)
Inactive Ingredients
Yellow Wax Coconut Oil Cocoa Butter Safflower Oil Glyceryl 1-undecylenate Olive Oil Triethoxycaprylylsilane Chamomile Mangifera Indica Seed Butter .alpha.-tocopherol Acetate Shea Butter Avocado Oil Glyceryl Caprylate Sunflower Oil Almond Oil Alkyl (c12-15) Benzoate Candelilla Wax Lavender Oil Aloe Vera Leaf Comfrey

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-11-04

Description

Zinc Oxide

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide

Uses

Helps prevent sunburn. Used as directed with other sun proctection measures, decreases skin cancer risk and early skin aging, caused by the sun.

Section 51945-4

Caution

Keep out of direct sunlight and excessive heat. Some natural seperation may occur. Shake well before using.

Warnings

For external use only. Do not ingest. Keep out of eyes; rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact poison control.

Sun Alert:

Limiting sun exposure, wearing protective clothing, and using broad spectrum sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Active Ingredient

Zinc Oxide

Other Information

Protect this product from excessive heat or direct sun.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Beeswax, Butyrospermum parkii (Shea) Butter, C12-15 Alkyl Benzoate, Candelilla (Euphorbia Cerifera) Wax, Carthamus tinctorius (Safflower) Seed Oil, Chamomilla recutita (Matricaria) Flower Extract, Cocos nucifera (Coconut) Oil, Glyceryl Caprylate, Glyceryl Undecylenate, Helianthus annuus (Sunflower) Seed Oil, Lavandula angustifolia (Lavender) Oil, Mangifera indica (Mango) Seed Butter, Olea europaea (Olive) Fruit Oil, Persea gratissima (Avocado) Oil, Symphytum officinale (Comfrey) Leat Extract, Theobroma cacao (Cocoa) Seed Butter, Tocopherol, Triethoxycaprylylsiloxane

Directions: Fda Recommends
  • Applying 15 minutes before sun exposure
  • Using a water resistant sunscreen if swimming or sweating
  • Reapplying at least every 2 hours
  • For children under 6 months: consult pediatrician

Structured Label Content

Uses

Helps prevent sunburn. Used as directed with other sun proctection measures, decreases skin cancer risk and early skin aging, caused by the sun.

Section 51945-4 (51945-4)

Caution

Keep out of direct sunlight and excessive heat. Some natural seperation may occur. Shake well before using.

Purpose

Sunscreen

Warnings

For external use only. Do not ingest. Keep out of eyes; rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact poison control.

Sun Alert:

Limiting sun exposure, wearing protective clothing, and using broad spectrum sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Active Ingredient

Zinc Oxide

Other Information

Protect this product from excessive heat or direct sun.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Beeswax, Butyrospermum parkii (Shea) Butter, C12-15 Alkyl Benzoate, Candelilla (Euphorbia Cerifera) Wax, Carthamus tinctorius (Safflower) Seed Oil, Chamomilla recutita (Matricaria) Flower Extract, Cocos nucifera (Coconut) Oil, Glyceryl Caprylate, Glyceryl Undecylenate, Helianthus annuus (Sunflower) Seed Oil, Lavandula angustifolia (Lavender) Oil, Mangifera indica (Mango) Seed Butter, Olea europaea (Olive) Fruit Oil, Persea gratissima (Avocado) Oil, Symphytum officinale (Comfrey) Leat Extract, Theobroma cacao (Cocoa) Seed Butter, Tocopherol, Triethoxycaprylylsiloxane

Directions: Fda Recommends (Directions: FDA Recommends)
  • Applying 15 minutes before sun exposure
  • Using a water resistant sunscreen if swimming or sweating
  • Reapplying at least every 2 hours
  • For children under 6 months: consult pediatrician

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)