SPL v2
SPL
SPL Set ID 1b4f307c-29bb-4b3e-9643-e9022aee349e
Route
TOPICAL
Published
Effective Date 2012-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (100 mg) Zinc Oxide (30 mg)
Inactive Ingredients
Butylene Glycol Butylparaben Medium-chain Triglycerides Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Cetostearyl Alcohol Cyclomethicone Dimethicone Edetate Disodium Glyceryl Monostearate Ferric Oxide Yellow Ferrosoferric Oxide Isobutylparaben Isopropylparaben Lemon Balm Oil Octyldodecyl Neopentanoate Polyoxyl 100 Stearate Phenoxyethanol Vitamin A Palmitate Sorbitan Monolaurate Talc Alpha-tocopherol .alpha.-tocopherol Acetate Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2004-01-02
Description

DRUG FACTS

Purpose

Sunscreen Sunscreen

Medication Information

Purpose

Sunscreen

Sunscreen

Description

DRUG FACTS

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 42229-5

DRUG FACTS

Section 50565-1

Keep out of the 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 51945-4

Principal Display Panel – Carton Label

NDC 58892-911-88

SOLAR

PROTECTION

FORMULA®

Gentle Mineral

Sunscreen

SPF 58

Broad Spectrum

Water Resistent

(40 minutes)

Net Wt. 2.5 Oz./ 70g

Warnings:

For external use only.

Directions:
  • Apply liberally 15 minutes before sun exposure.
  • Reapply:
    • After 40 minutes of swimming or sweating
    • Immediately after towel drying
    • At least every 2 hours
  • Children under 6 months: Ask a doctor
  • 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:
    • Limit time in the sun, especially from 10:00 a.m.-2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses.
Other Information:
  • Protect this product from excessive heat and direct sun
  • May stain some fabrics
Active Ingredients:

Titanium Dioxide 10%

Zinc Oxide 3%

Inactive Ingredients:

Acrylates C10-30 Alkyl Acrylates Crosspolymer, Butylene Glycol, Butyloctyl Salicylate, Butylparaben, Capric/Caprylic Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cyclomethicone, Dimethicone, Ethylhexyl Hydroxystearate Benzoate, Glyceryl Stearate, Iron Oxides, Isobutylparaben, Isopropylparaben, Melissa Officinalis (Balm Mint) Extract, Octyldodecyl Neopentanoate, PEG-100 Stearate, Phenoxyethanol, Retinyl Palmitate, Simethicone, Sorbitan Laurate, Styrene/Acrylates Copolymer, Talc, Tocopherol, Tocopheryl Acetate, Tricontanyl PVP, Trisodium EDTA, Water, Xanthan Gum

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.

Section 42229-5 (42229-5)

DRUG FACTS

Section 50565-1 (50565-1)

Keep out of the 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 51945-4 (51945-4)

Principal Display Panel – Carton Label

NDC 58892-911-88

SOLAR

PROTECTION

FORMULA®

Gentle Mineral

Sunscreen

SPF 58

Broad Spectrum

Water Resistent

(40 minutes)

Net Wt. 2.5 Oz./ 70g

Purpose

Sunscreen

Sunscreen

Warnings:

For external use only.

Directions:
  • Apply liberally 15 minutes before sun exposure.
  • Reapply:
    • After 40 minutes of swimming or sweating
    • Immediately after towel drying
    • At least every 2 hours
  • Children under 6 months: Ask a doctor
  • 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:
    • Limit time in the sun, especially from 10:00 a.m.-2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses.
Other Information:
  • Protect this product from excessive heat and direct sun
  • May stain some fabrics
Active Ingredients:

Titanium Dioxide 10%

Zinc Oxide 3%

Inactive Ingredients:

Acrylates C10-30 Alkyl Acrylates Crosspolymer, Butylene Glycol, Butyloctyl Salicylate, Butylparaben, Capric/Caprylic Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cyclomethicone, Dimethicone, Ethylhexyl Hydroxystearate Benzoate, Glyceryl Stearate, Iron Oxides, Isobutylparaben, Isopropylparaben, Melissa Officinalis (Balm Mint) Extract, Octyldodecyl Neopentanoate, PEG-100 Stearate, Phenoxyethanol, Retinyl Palmitate, Simethicone, Sorbitan Laurate, Styrene/Acrylates Copolymer, Talc, Tocopherol, Tocopheryl Acetate, Tricontanyl PVP, Trisodium EDTA, Water, Xanthan Gum

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:34.779337 · Updated: 2026-03-14T22:53:23.299879