Raw Elements Baby+kids Broad Spectrum Spf30 Sunscreen Stick

Raw Elements Baby+kids Broad Spectrum Spf30 Sunscreen Stick
SPL v2
SPL
SPL Set ID a6e5f808-65c7-4810-a15c-413111216dae
Route
TOPICAL
Published
Effective Date 2019-06-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (250 mg)
Inactive Ingredients
Sunflower Oil Cocoa Butter Coconut Oil Helianthus Annuus Seed Wax Calendula Officinalis Flower Matricaria Chamomilla Rosemary Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-15

Description

Non-Nano Zinc Oxide 25%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Non-Nano Zinc Oxide 25%

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
Warnings

For external use only.

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
  • 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 of 15 or higher and other sun protection measures including: Sun Protection Measures.
  • limit time in the sun, especially from 10 a.m.-2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor
Do Not Use 

on damaged or broken skin.

Other Information
  • protect this product from excessive heat and direct sun
Package Labeling:

Active Ingredients

Non-Nano Zinc Oxide 25%

Inactive Ingredients

Organic Helianthus Annuus (Sunflower) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Cera Flava, Organic Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed wax, Calendula Officinalis Flower Extract, Organic Chamomilla Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol

Questions Or Comments?

Call toll free 1-888-442-6676

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


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
Purpose

Sunscreen

Warnings

For external use only.

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
  • 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 of 15 or higher and other sun protection measures including: Sun Protection Measures.
  • limit time in the sun, especially from 10 a.m.-2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor
Do Not Use  (Do not use )

on damaged or broken skin.

Other Information (Other information)
  • protect this product from excessive heat and direct sun
Package Labeling:

Active Ingredients

Non-Nano Zinc Oxide 25%

Inactive Ingredients (Inactive ingredients)

Organic Helianthus Annuus (Sunflower) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Cera Flava, Organic Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed wax, Calendula Officinalis Flower Extract, Organic Chamomilla Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol

Questions Or Comments? (Questions or comments?)

Call toll free 1-888-442-6676

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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