FDA.reportPublic FDA data

Drug Facts

Manufacturer
L'Oreal USA Products Inc | DPT Laboratories, Ltd.
Effective date
2023-12-31
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:16:21

Label at a glance#

ProductLa Roche Posay Laboratoire Dermatologique Anthelios SX Daily Moisturizing Sunscreen Broad Spectrum SPF 15
Active ingredientAVOBENZONE, ECAMSULE, OCTOCRYLENE
Label structure12 sections

Indications and uses

- helps prevent sunburn - higher SPF gives more sunburn protection - helps provide protection from UVA rays (short and long wavelengths)

Dosage and administration

- apply evenly before sun exposure - reapply as needed or after towel drying, swimming, or perspiring - children under 6 months of age: ask a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION


Avobenzone 2%

Ecamsule 2%

Octocrylene 10%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

- helps prevent sunburn

- higher SPF gives more sunburn protection

- helps provide protection from UVA rays (short and long wavelengths)

Warnings

WARNINGS SECTION

For external use only

Do not use on

OTC - DO NOT USE SECTION

- broken skin

- serious burns

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 or irritation develops and lasts

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 evenly before sun exposure

- reapply as needed or after towel drying, swimming, or perspiring

- children under 6 months of age: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer homopolymer Type C, carbomer copolymer Type B, cyclomethicone, dimethicone, edetate disodium, glycerin, hydroxypropyl methylcellulose, isopropyl palmitate, methylparaben, phenoxyethanol, propylene glycol, propylparaben, purified water, stearic acid, stearoyl macrogolglycerides, stearyl alcohol, trolamine

Questions?

OTC - QUESTIONS SECTION

1-800-308-4516

Monday - Friday (9 a.m. to 5 p.m. EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a cartonimage of a carton

image of a carton
image of a carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX2
ECAMSULEACTIVE INGREDIENTM94R1PM4392
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM2
AVOBENZONEACTIVE MOIETYG63QQF2NOX2
ECAMSULEACTIVE MOIETYM94R1PM4392
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM2

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-01749967-017-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
ECAMSULEM94R1PM439ACTIB
OCTOCRYLENE5A68WGF6WMACTIB
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED)K6MOM3T5YLIACT
CYCLOMETHICONENMQ347994ZIACT
DIMETHICONE92RU3N3Y1OIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
METHYLPARABENA2I8C7HI9TIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
PEG-32 HYDROGENATED PALM GLYCERIDESG6EP177239IACT
STEARYL ALCOHOL2KR89I4H1YIACT
TROLAMINE9O3K93S3TKIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021502-001ANTHELIOS SXAVOBENZONE; ECAMSULE; OCTOCRYLENE2%;2%;10%CREAM / TOPICALRLD, RS2006-07-21

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-2184e616aacf4f…
2026-08-18 06:07:402026-07N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-2187673890dc5c…
2021-03-12 10:30 UTC2021-03N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-213f01610625f2…
2019-09-15 20:21 UTC2019-09N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-21b00525d2431f…
2019-07-19 19:46 UTC2019-07N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-213f0d92c62455…
2023-05-13 08:27 UTC2023-05N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-21053a50430f4f…
2023-01-26 05:58 UTC2023-01N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021502-001ANTHELIOS SX2%;2%;10%CREAM / TOPICALRLD, RS2006-07-21f41ea6bd6efb…

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
b0482516-fafc-4b0f-aea1-1e20a276d1f1de3fd7fb-4a28-4db8-9a4d-d7fdd2e45daf2023-12-31WarningsExact identifier
spl id: b0482516-fafc-4b0f-aea1-1e20a276d1f1
spl set id: de3fd7fb-4a28-4db8-9a4d-d7fdd2e45daf

Reported adverse events (FAERS/openFDA)#

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