Sunblock Drug Fact

SPL v2

SPL

SPL Set ID f9e0f06c-3c58-4070-b29b-7df35cc2aa4e

Route

TOPICAL

Published

Effective Date 2010-06-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Octinoxate (8 mL) Oxybenzone (7.5 mL) Titanium Dioxide (6 mL) Homosalate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2010-06-30

Description

OctylMethoxycinnamate,Benzophenone-3,Homosalate, Titanium dioxide

Medication Information

Description

OctylMethoxycinnamate,Benzophenone-3,Homosalate, Titanium dioxide

Use

Protection from the sun’s damaging effects

Section 51945-4

Warnings

For external use only

Not recommended for children under 6 months of age

Direction

Apply liberally and evenly before sun exposure.

Active Ingredient

OctylMethoxycinnamate,Benzophenone-3,Homosalate, Titanium dioxide

Inactive Ingredient

Water,CetearylAlcohol,Glycerinmonostearate,

Gctt,Propylparaben,Methylparaben,

glycerol,EDTA-2NA,Vinylchloride-methylacrylate,

copolymer,Methylisothiazolinone

Structured Label Content

Use

Protection from the sun’s damaging effects

Section 51945-4 (51945-4)

Warnings

For external use only

Not recommended for children under 6 months of age

Direction

Apply liberally and evenly before sun exposure.

Active Ingredient

OctylMethoxycinnamate,Benzophenone-3,Homosalate, Titanium dioxide

Inactive Ingredient

Water,CetearylAlcohol,Glycerinmonostearate,

Gctt,Propylparaben,Methylparaben,

glycerol,EDTA-2NA,Vinylchloride-methylacrylate,

copolymer,Methylisothiazolinone

Advanced Ingredient Data

[{"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "OXYBENZONE", "unii": "95OOS7VE0Y", "classCode": "ACTIB", "strengthNumerator": "7.5", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "Protection from the sun’s damaging effects", "Warnings": "For external use only Not recommended for children under 6 months of age", "Direction": "Apply liberally and evenly before sun exposure. ", "Active Ingredient": "OctylMethoxycinnamate,Benzophenone-3,Homosalate, Titanium dioxide", "Inactive Ingredient": "Water,CetearylAlcohol,Glycerinmonostearate, Gctt,Propylparaben,Methylparaben, glycerol,EDTA-2NA,Vinylchloride-methylacrylate, copolymer,Methylisothiazolinone "}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:05.705112 · Updated: 2026-03-14T22:52:25.436081