reef safe unscented spf 50 mineral sunscreen

reef safe unscented spf 50 mineral sunscreen
SPL v1
SPL
SPL Set ID 286965aa-0961-0141-e063-6394a90aa3f0
Route
topical
Published
Effective Date 2024-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octocrylene (10 g) homosalate (3 g) avobenzone (5 g) octisalate
Inactive Ingredients
glycerin vp/hexadecene copolymer tocopherol pvp glycine max (soybean) oil isononyl isononanoate phenoxyethanol cetostearyl alcohol ceteth-25 edetate disodium peg-100 stearate water glyceryl stearate se alkyl (c12-15) benzoate triethoxycaprylylsilane dimethicone xanthan gum ethylhexylglycerin silica

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-12-03
Purpose

Sunscreen

Description

Drug Facts

Medication Information

Warnings and Precautions

For external use only

Warnings

For external use only

Uses
  • Helps prevent sunburn
  • Higher SPF giwes more sunburn protection
Purpose

Sunscreen

Directions
  • apply liberally 15minutes before sun exposure as needed
  • Children under 6 months of age: ask a doctor before use.
  • reapply at least every 2 hours.
  • use a water resistant sunscreen if swimming or sweating.

Sun Protection Measures

Spending time in the sun increases your risk of skin cancer and early skin aging.

To decreases this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10a.m.- 2p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
Other Information

Protect this product from excessive heat and direct sun

Inactive Ingredients

AQUA(WATER), ISONONYL ISONONANOATE, C12-15 ALKYL BENZOATE, DIMETHICONE, GLYCERIN, CETETH-25, CETEARYL ALCOHOL, SILICA, VP/HEXADECENE COPOLYMER, GLYCERYL STEARATE, PEG-100 STEARATE, PHENOXYETHANOL, TOCOPHEROL, XANTHAN GUM, PVP, ETHYLHEXYLGLYCERIN, GLYCINE MAX (SOYBEAN) OIL, DISODIUM EDTA, TRIETHOXYCAPRYLYLSILANE

Description

Drug Facts

Section 42229-5

Drug Facts

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 or irritation develops and persists.

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 51945-4

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octocrylene 10%

Octisalate 5%

Skin Cancer/skin Aging Alert:

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sumburn, not skin cancer or early skin aging.

Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Warnings

For external use only

Uses
  • Helps prevent sunburn
  • Higher SPF giwes more sunburn protection
Purpose

Sunscreen

Directions
  • apply liberally 15minutes before sun exposure as needed
  • Children under 6 months of age: ask a doctor before use.
  • reapply at least every 2 hours.
  • use a water resistant sunscreen if swimming or sweating.

Sun Protection Measures

Spending time in the sun increases your risk of skin cancer and early skin aging.

To decreases this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10a.m.- 2p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
Other Information (Other information)

Protect this product from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

AQUA(WATER), ISONONYL ISONONANOATE, C12-15 ALKYL BENZOATE, DIMETHICONE, GLYCERIN, CETETH-25, CETEARYL ALCOHOL, SILICA, VP/HEXADECENE COPOLYMER, GLYCERYL STEARATE, PEG-100 STEARATE, PHENOXYETHANOL, TOCOPHEROL, XANTHAN GUM, PVP, ETHYLHEXYLGLYCERIN, GLYCINE MAX (SOYBEAN) OIL, DISODIUM EDTA, TRIETHOXYCAPRYLYLSILANE

Section 42229-5 (42229-5)

Drug Facts

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 or irritation develops and persists.

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 51945-4 (51945-4)

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 10%

Octocrylene 10%

Octisalate 5%

Skin Cancer/skin Aging Alert: (Skin Cancer/Skin Aging Alert:)

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sumburn, not skin cancer or early skin aging.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:36.044 · Updated: 2026-03-14T23:05:28.061539