92204 All Good Mineral Sport Sunscreen Butter Stick Spf 50 (english-only Us Label)

92204 All Good Mineral Sport Sunscreen Butter Stick Spf 50 (english-only Us Label)
SPL v3
SPL
SPL Set ID 114c6ac8-b133-cd16-e063-6294a90ac4f9
Route
TOPICAL
Published
Effective Date 2022-02-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (25 g)
Inactive Ingredients
Coconut Oil Tocopherol Calendula Officinalis Flower White Wax Jojoba Oil

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-15

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

  • For external use only.
Indications and Usage

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.

Dosage and Administration

Directions

  • Apply liberally/generously (and evenly) 15 minutes before sun exposure
  • Reapply
  • After 80 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours.
  • Children under 6 months: ask a doctor

Sun Protection Measure: 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 un protection measures including:

  • Limit time in the sun, especially from 10 a.m. to 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sun glasses.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 43683-2

Artwork updated to remove bi-lingual text (for Canadian market). Label is now English-only for US market.

Section 44425-7

Other information:

Protect this product from excessive heat and direct sun.

Section 50565-1
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9
  • Stop use and ask a doctor if rash occurs.
Section 50567-7
  • When using this product keep out of eyes. Rinse with water to remove.
Section 50570-1
  • Do not use on damaged or broken skin.
Section 51727-6

Inactive Ingredients

Cocos Nucifera (Coconut) Oil*, Cera Alba (Beeswax)*, Simmondsia Chinensis (Jojoba) Seed Oil* 9and) Calendula Officinalis Flower*, Non-GMO Tocopherol (Vitamin E).

*CERTIFIED ORGANIC INGREDIENT

Section 53413-1

Questions or Commnets?

Call (877)239-4667 M-F between 8:00am-4:00pm CST

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active Ingredient

Zinc Oxide 25%

Principal Display Panel


Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

Directions

  • Apply liberally/generously (and evenly) 15 minutes before sun exposure
  • Reapply
  • After 80 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours.
  • Children under 6 months: ask a doctor

Sun Protection Measure: 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 un protection measures including:

  • Limit time in the sun, especially from 10 a.m. to 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sun glasses.

Warnings and Precautions (34071-1)

Warnings

  • For external use only.
Section 42229-5 (42229-5)

Drug Facts

Section 43683-2 (43683-2)

Artwork updated to remove bi-lingual text (for Canadian market). Label is now English-only for US market.

Section 44425-7 (44425-7)

Other information:

Protect this product from excessive heat and direct sun.

Section 50565-1 (50565-1)
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
  • Stop use and ask a doctor if rash occurs.
Section 50567-7 (50567-7)
  • When using this product keep out of eyes. Rinse with water to remove.
Section 50570-1 (50570-1)
  • Do not use on damaged or broken skin.
Section 51727-6 (51727-6)

Inactive Ingredients

Cocos Nucifera (Coconut) Oil*, Cera Alba (Beeswax)*, Simmondsia Chinensis (Jojoba) Seed Oil* 9and) Calendula Officinalis Flower*, Non-GMO Tocopherol (Vitamin E).

*CERTIFIED ORGANIC INGREDIENT

Section 53413-1 (53413-1)

Questions or Commnets?

Call (877)239-4667 M-F between 8:00am-4:00pm CST

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Active Ingredient

Zinc Oxide 25%

Principal Display Panel


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)