FDA.reportPublic FDA data

SOLAR MILK SPF50

Manufacturer
COSMAX USA, CORPORATION
Effective date
2024-12-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:48:45

Label at a glance#

ProductSOLAR MILK SPF50
Active ingredientAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Label structure7 sections

Indications and uses

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

Directions apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months of age ask a doctor Sun Protection Measures. Spending time in the sun increases you risk of skin cancer and ealy skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection m...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

OTC - PURPOSE SECTION

Purpose

Sunscreen

USES

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

Warnings

  • For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • rash or irritation develops and lasts

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

INDICATIONS & USAGE SECTION

Directions

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months of age ask a doctor Sun Protection Measures. Spending time in the sun increases you risk of skin cancer and ealy 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.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Isododecane, Dimethicone/Bis-lsobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylyl Methicone, Tocopheryl Acetate Pongamia Glabra Seed Oil, Oryza Saliva (Rice) Bran Extract, Silica, Helianthus Annuus (Sunflower) Extract, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Dunaliella Salina (Algae) Extract, Haematococcus Pluvialis Extract, Caprae Lac (Goat Milk), Cocos Nucifera (Coconut) Fruit Extract, Lactobacillus/Rice Ferment, Maltitol, Arginine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bottlebottleFront PanelFront PanelPanelPanel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-197-00SOLAR MILK SPF501 in 1 CARTONGEL11
68577-197-00SOLAR MILK SPF5050 mL in 1 BOTTLEGEL501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68577-197SOLAR MILK SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [COSMAX USA, CORPORATION]1Current NDC, 2 package rows20241227_29fe4dad-d1fb-e750-e063-6294a90ab307.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68577-19768577-197-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
MALTITOLD65DG142WKIACT
ARGININE94ZLA3W45FIACT
ORYZA SATIVA (RICE) BRANR60QEP13ICIACT
TOCOPHEROLR0ZB2556P8IACT
ROSEMARYIJ67X351P9IACT
COCOS NUCIFERA (COCONUT) FRUIT3RT3536DHYIACT
ISODODECANEA8289P68Y2IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
AVOBENZONEG63QQF2NOXACTIB
HAEMATOCOCCUS PLUVIALIS31T0FF0472IACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
CAPRYLYL METHICONEQ95M2P1KJLIACT
SILICAETJ7Z6XBU4IACT
GOAT MILKXE5K5I4RP7IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
OCTISALATE4X49Y0596WACTIB
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMERO4I3UFO6ZFIACT

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
SOLAR MILK SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION29fe4dad-d1fb-e750-e063-6294a90ab3072024-12-24WarningsExact identifier
ndc (package): 68577-197-00
ndc (product): 68577-197
ndc11 (package): 68577019700
spl id: 29fe4dad-d1fc-e750-e063-6294a90ab307
spl set id: 29fe4dad-d1fb-e750-e063-6294a90ab307

Reported adverse events (FAERS/openFDA)#

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