spf 45 - lip balm

Generic: avobenzone, homosalate, octinoxate, octisalate, petrolatum

Labeler: oralabs
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name spf 45 - lip balm
Generic Name avobenzone, homosalate, octinoxate, octisalate, petrolatum
Labeler oralabs
Dosage Form STICK
Routes
TOPICAL
Active Ingredients

avobenzone 30 mg/g, homosalate 30 mg/g, octinoxate 75 mg/g, octisalate 50 mg/g, petrolatum 400 mg/g

Manufacturer
OraLabs

Identifiers & Regulatory

Product NDC 63645-183
Product ID 63645-183_3363a160-68b7-c576-e063-6294a90a8768
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 352
Listing Expiration 2026-12-31
Marketing Start 2023-06-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63645183
Hyphenated Format 63645-183

Supplemental Identifiers

UNII
G63QQF2NOX V06SV4M95S 4Y5P7MUD51 4X49Y0596W 4T6H12BN9U

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name spf 45 - lip balm (source: ndc)
Generic Name avobenzone, homosalate, octinoxate, octisalate, petrolatum (source: ndc)
Application Number 352 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/g
  • 75 mg/g
  • 50 mg/g
  • 400 mg/g
source: ndc
Packaging
  • 4 g in 1 CONTAINER (63645-183-01)
source: ndc

Packages (1)

63645-183-01 4 g in 1 CONTAINER (63645-183-01)

Ingredients (5)

avobenzone (30 mg/g) homosalate (30 mg/g) octinoxate (75 mg/g) octisalate (50 mg/g) petrolatum (400 mg/g)

Linked Drug Pages (1)

SPF 45 - Lip Balm ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3363a160-68b7-c576-e063-6294a90a8768", "openfda": {"unii": ["G63QQF2NOX", "V06SV4M95S", "4Y5P7MUD51", "4X49Y0596W", "4T6H12BN9U"], "spl_set_id": ["afd10abe-1e8b-4df8-9d8c-ef15266c510c"], "manufacturer_name": ["OraLabs"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 g in 1 CONTAINER (63645-183-01)", "package_ndc": "63645-183-01", "marketing_start_date": "20230601"}], "brand_name": "SPF 45 - Lip Balm", "product_id": "63645-183_3363a160-68b7-c576-e063-6294a90a8768", "dosage_form": "STICK", "product_ndc": "63645-183", "generic_name": "Avobenzone, Homosalate, Octinoxate, Octisalate, Petrolatum", "labeler_name": "OraLabs", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SPF 45 - Lip Balm", "active_ingredients": [{"name": "AVOBENZONE", "strength": "30 mg/g"}, {"name": "HOMOSALATE", "strength": "30 mg/g"}, {"name": "OCTINOXATE", "strength": "75 mg/g"}, {"name": "OCTISALATE", "strength": "50 mg/g"}, {"name": "PETROLATUM", "strength": "400 mg/g"}], "application_number": "352", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230601", "listing_expiration_date": "20261231"}