51f5015a-c0db-449a-ae28-bde77eef562e

SPL v3
SPL
SPL Set ID 51f5015a-c0db-449a-ae28-bde77eef562e
Route
topical
Published
Effective Date 2015-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc cation (40.4 mg) titanium dioxide (45.45 mg)
Inactive Ingredients
cetyl alcohol propylene glycol water stearyl alcohol aluminum hydroxide stearic acid triethoxycaprylylsilane butyl acrylate/c16-c20 alkyl methacrylate/methacrylic acid/methyl methacrylate copolymer alkyl (c12-15) benzoate polyoxyl 20 cetostearyl ether citric acid monohydrate dibutyl adipate dimethicone trimethylsiloxysilicate (m/q 0.6-0.8) glycerin hexyl laurate magnesium aluminum silicate methylcellulose (100 cps) peg-12 dimethicone (300 cst) phenoxyethanol polyglyceryl-3 distearate sodium hydroxide methylisothiazolinone artemisia princeps whole buddleja davidii whole xanthan gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph final active Since 2014-11-18
Purpose

Sunscreen

Description

Titanium Dioxide 4.5 %, and Zinc Oxide 4 %

Medication Information

Warnings

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

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
  • 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 of 15 or higher and other sun protection measures including:
    • 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
Other Information
  • protect this product from excesive heat and direct sun
Inactive Ingredients

Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aluminum Hydroxide, Artemisia Princeps (Yomogi) Extract, Buddleja Davidii (Butterfly Bush) Extract, C12-15 Alkyl Benzoate, Ceteareth-20, Cetyl Alcohol, Dibutly Adipate, Dimethicone, Fragrance (Parfum), Glycerin, Hexyl Laurate, Magnesium Aluminum Silicate, Methylcellulose, Methylisothiazolinone, PEG-12 Dimethicone, Phenoxyethanol, Polyglyceryl-3 Distearate, Propylene Glycol, Stearic Acid, Stearyl Alcohol, Triethoxycaprylylsilane, Trimethylsiloxysilicate, Water (Aqua), Xanthan Gum, may contain Citric Acid, may contain Sodium Hydroxide

Description

Titanium Dioxide 4.5 %, and Zinc Oxide 4 %

Section 50565-1

Keep out of reach of children. If product is 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 60561-8

For external use only

Active Ingredients

Titanium Dioxide 4.5 %, and Zinc Oxide 4 %

Questions Or Comments?

Call toll free 1-855-LIV-GOLD (548-4653)

Principal Display Panel  150 ml  bottle Label

Australian G old

HELLO

KITTY

Mineral

Sunscreen Lotion

Sweet Starfruit

50

BROAD SPECTRUM SPF 50

Water Resistant (80 minutes)

5 FL OZ (150 mL)

Structured Label Content

Warnings

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

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
  • 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 of 15 or higher and other sun protection measures including:
    • 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
Other Information (Other information)
  • protect this product from excesive heat and direct sun
Inactive Ingredients (Inactive ingredients)

Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aluminum Hydroxide, Artemisia Princeps (Yomogi) Extract, Buddleja Davidii (Butterfly Bush) Extract, C12-15 Alkyl Benzoate, Ceteareth-20, Cetyl Alcohol, Dibutly Adipate, Dimethicone, Fragrance (Parfum), Glycerin, Hexyl Laurate, Magnesium Aluminum Silicate, Methylcellulose, Methylisothiazolinone, PEG-12 Dimethicone, Phenoxyethanol, Polyglyceryl-3 Distearate, Propylene Glycol, Stearic Acid, Stearyl Alcohol, Triethoxycaprylylsilane, Trimethylsiloxysilicate, Water (Aqua), Xanthan Gum, may contain Citric Acid, may contain Sodium Hydroxide

Section 50565-1 (50565-1)

Keep out of reach of children. If product is 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 60561-8 (60561-8)

For external use only

Active Ingredients (Active ingredients)

Titanium Dioxide 4.5 %, and Zinc Oxide 4 %

Questions Or Comments? (Questions or Comments?)

Call toll free 1-855-LIV-GOLD (548-4653)

Principal Display Panel  150 ml  bottle Label (PRINCIPAL DISPLAY PANEL - 150 mL  Bottle Label)

Australian G old

HELLO

KITTY

Mineral

Sunscreen Lotion

Sweet Starfruit

50

BROAD SPECTRUM SPF 50

Water Resistant (80 minutes)

5 FL OZ (150 mL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:01.174981 · Updated: 2026-03-14T22:55:52.022027