FDA.reportPublic FDA data

Sunscreen Lotion Face and Body Broad Spectrum SPF 30

Manufacturer
Sothys Paris | Cofran International Corp
Effective date
2020-01-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:44:29

Label at a glance#

ProductSunscreen Face and Body Broad Spectrum SPF 30
Active ingredientOCTOCRYLENE, OCTINOXATE, OXYBENZONE, AVOBENZONE
Label structure7 sections

Indications and 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.

Dosage and administration

Apply liberally 15 minutes before sun exposure 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 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 ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 10%
Octyl methoxycinnamate 7.5%
Oxybenzone 5%
Avobenzone 3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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.

Warnings:

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin
  • in the eye contour

When using this product

OTC - WHEN USING SECTION

  • Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • 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 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 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats and sunglasses
  • Children under 6 months of age: Ask a doctor

Other information

SPL UNCLASSIFIED SECTION

Protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylamide/sodium acryloyldimethyltaurate copolymer, Ammonium acryloyldimethyltaurate/ VP copolymer, Aqua (Water), Butylene glycol, C12-15 alkyl benzoate, Caprylhydroxamic acid, Caprylyl glycol, Dicaprylyl carbonate, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl stearate, Helianthus annuus (Sunflower) seed extract, Isohexadecane, Parfum (Fragrance), PEG-100 stearate, Phenoxyethanol, Polymethyl methacrylate, Polysorbate 80, Potassium Cetyl phosphate, Sorbitan oleate, Sorbitan stearate, Tocopherol, Tocopheryl acetate, VP/eicosene
copolymer

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLotionLotion

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51683-00251683-002-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CAPRYLYL GLYCOL00YIU5438UIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SUNFLOWER SEEDR9N3379M4ZIACT
ISOHEXADECANE918X1OUF1EIACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
POLYSORBATE 806OZP39ZG8HIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
TOCOPHEROLR0ZB2556P8IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
OCTOCRYLENE5A68WGF6WMACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
AVOBENZONEG63QQF2NOXACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
eec659bb-c087-7d2f-e053-2995a90a1da83517751e-e5f0-4001-bc83-712b6a0781ee2023-01-19WarningsExact identifier
spl set id: 3517751e-e5f0-4001-bc83-712b6a0781ee

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.