Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 787419e7-30ce-40c1-b2b9-98e3ac17df59
Route
TOPICAL
Published
Effective Date 2021-01-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (22 g)
Inactive Ingredients
Sunflower Oil Coconut Oil Candelilla Wax Castor Oil Raspberry Seed Oil Apricot Kernel Oil Argan Oil Carnauba Wax Aloe Vera Leaf Tocopherol Rosa Canina Fruit Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-02-01
Description

Zinc Oxide - 20.0%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Zinc Oxide - 20.0%

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 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
Warning:

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
  • For children under 6 months of age: ask a doctor
Active Ingredients

Zinc Oxide - 20.0%

Inactive Ingredients:

Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (Coconut) Oil*, Euphorbia Cerifera (Candelilla) Wax, Ricinus Communis (Castor) Seed Oil, Rubus Idaeus (Red Raspberry) Seed Oil, Butyrospermum Parkii (Shea) Butter*, Prunus Armeniaca (Apricot) Kernel Oil, Argania Spinosa (Argan) Kernel Oil*, Copernicia Cerifera (Carnauba) Wax*, Rosa Canina (Rosehip) Fruit Oil, Tocopherol - *Certified Organic

Sun Protection Measures:

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 sun protection measures including: limited time in the sun, especially from 10 am. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses.

Principal Display Panel 29 G Box Label

hello

bello

Mineral

Sunscreen

Stick

30

SPF

1.0 fl oz (29 g) e

Principal Display Panel 29 G Stick Label

hello

bello

Mineral

Sunscreen

Stick

30

SPF

1.0 fl oz (29 g) e

Reef

Friendly

Vegan

Principal Display Panel 88.7 Ml Carton Label

50+

SPF

Broad Spectrum UVA + UVB Protection

Non- Nano Zinc Oxide

hello

bello™

• Dermatologist Tested

• Clinically Tested • Non-Greasy

• Hypoallergenic

Safe & Effective for

Adults & Kids

Mineral

Sunscreen

3.0 fl. oz. (88.7 ml) e

Reef

Friendly

Water Resistant

(80 Minutes)

Structured Label Content

Uses: (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 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
Purpose (PURPOSE)

Sunscreen

Warning: (WARNING:)

For external use only

Directions: (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
  • For children under 6 months of age: ask a doctor
Active Ingredients (ACTIVE INGREDIENTS)

Zinc Oxide - 20.0%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (Coconut) Oil*, Euphorbia Cerifera (Candelilla) Wax, Ricinus Communis (Castor) Seed Oil, Rubus Idaeus (Red Raspberry) Seed Oil, Butyrospermum Parkii (Shea) Butter*, Prunus Armeniaca (Apricot) Kernel Oil, Argania Spinosa (Argan) Kernel Oil*, Copernicia Cerifera (Carnauba) Wax*, Rosa Canina (Rosehip) Fruit Oil, Tocopherol - *Certified Organic

Sun Protection Measures: (SUN PROTECTION MEASURES:)

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 sun protection measures including: limited time in the sun, especially from 10 am. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses.

Principal Display Panel 29 G Box Label (Principal Display Panel - 29 g Box Label)

hello

bello

Mineral

Sunscreen

Stick

30

SPF

1.0 fl oz (29 g) e

Principal Display Panel 29 G Stick Label (Principal Display Panel - 29 g Stick Label)

hello

bello

Mineral

Sunscreen

Stick

30

SPF

1.0 fl oz (29 g) e

Reef

Friendly

Vegan

Principal Display Panel 88.7 Ml Carton Label (Principal Display Panel - 88.7 mL Carton Label)

50+

SPF

Broad Spectrum UVA + UVB Protection

Non- Nano Zinc Oxide

hello

bello™

• Dermatologist Tested

• Clinically Tested • Non-Greasy

• Hypoallergenic

Safe & Effective for

Adults & Kids

Mineral

Sunscreen

3.0 fl. oz. (88.7 ml) e

Reef

Friendly

Water Resistant

(80 Minutes)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:20.561183 · Updated: 2026-03-14T22:59:16.552832