SPL v3
SPL
SPL Set ID e5201105-75c4-496d-b1cb-d6d01e280455
Route
TOPICAL
Published
Effective Date 2015-02-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (76.5 mg) Octisalate (51 mg) Zinc Cation (45.9 mg)
Inactive Ingredients
Sodium Hydroxide Stearic Acid .alpha.-tocopherol Acetate Trideceth-6 Water Caprylic/capric Mono/diglycerides Sodium Acryloyldimethyltaurate-acrylamide Copolymer (1:1; 90000-150000 Mpa.s) Aloe Vera Leaf Green Tea Leaf Cetostearyl Alcohol Ethylhexylglycerin Glycerin Glyceryl Stearate Se Sunflower Seed Oil Glycereth-8 Esters Mineral Oil Phenoxyethanol Propylene Glycol Sodium Cocoyl Glutamate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-04-01
Description

Octinozate 7.5% ,Octisalate 5%, and Zinc Oxide 4.5%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Octinozate 7.5% ,Octisalate 5%, and Zinc Oxide 4.5%

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 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.

Warnings

Directions:
  • apply liberally 15 minutes before sun exposure
  • reapply:
  • immediately after towel drying
  • at least every 2 hours
  • Sun Protection Measures:  Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher & 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 excessive heat and direct sun
  • may stain or damage some fabrics or sufaces
Active Ingredients

Octinozate 7.5% ,Octisalate 5%, and Zinc Oxide 4.5%

Inactive Ingredients

acrylamide sodium acrylate copolymer, aloe barbadensis leaf juice, camellia sinensis (green tea) leaf extract, caprylic/capric tiglyceride, cetearyl alcohol, ethylhexylglycerin, fragrance, glycerin, glyceryl stearate, helianthus annuus (sunflower) seed oil, mineral oil, phenoxyethanol, propylene glycol, sodium cocoyl glucamate, sodium hydroxide, stearic acid, tocopheryl acetate, trideceth-6, water.

Questions Or Comments?

SolScents, LLC

2200 N.W. 92nd Avenue.

Miami, FL 33172

Principal Display Panel  100 ml  bottle Label

SolScents

SUNSCREEN

CLEAR FACE

SKIN NOUISHING ANTIOXIDANTS

FLOWER BLAST

50

Broad Spectrum SPF50

Paraben Free

Ultra-light

MADE IN TE USA

3.4 FL OZ (100 mL)

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 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.

Purpose

Sunscreen

Warnings

Directions:
  • apply liberally 15 minutes before sun exposure
  • reapply:
  • immediately after towel drying
  • at least every 2 hours
  • Sun Protection Measures:  Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher & 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 excessive heat and direct sun
  • may stain or damage some fabrics or sufaces
Active Ingredients (Active ingredients)

Octinozate 7.5% ,Octisalate 5%, and Zinc Oxide 4.5%

Inactive Ingredients

acrylamide sodium acrylate copolymer, aloe barbadensis leaf juice, camellia sinensis (green tea) leaf extract, caprylic/capric tiglyceride, cetearyl alcohol, ethylhexylglycerin, fragrance, glycerin, glyceryl stearate, helianthus annuus (sunflower) seed oil, mineral oil, phenoxyethanol, propylene glycol, sodium cocoyl glucamate, sodium hydroxide, stearic acid, tocopheryl acetate, trideceth-6, water.

Questions Or Comments? (Questions or comments?)

SolScents, LLC

2200 N.W. 92nd Avenue.

Miami, FL 33172

Principal Display Panel  100 ml  bottle Label (PRINCIPAL DISPLAY PANEL - 100 mL  Bottle Label)

SolScents

SUNSCREEN

CLEAR FACE

SKIN NOUISHING ANTIOXIDANTS

FLOWER BLAST

50

Broad Spectrum SPF50

Paraben Free

Ultra-light

MADE IN TE USA

3.4 FL OZ (100 mL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:01.742676 · Updated: 2026-03-14T22:55:52.022027